Alpine Biomed ApS

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Electrical, Evoked Response (GWF) (10)

Premarket Exempt

No Yes

Clear

Alpine BioMed - 05704736017114 Catalog Number :

Device Description : "Keypoint Focus Notebook System, Intl. 115V ENGIncluding:- Notebook PC with Keyp "Keypoint Focus Notebook System, Intl. 115V ENGIncluding:- Notebook PC with Keypoint software- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017121 Catalog Number :

Device Description : "Keypoint Focus Notebook System, Intl. 230V ENGIncluding:- Notebook PC with Keyp "Keypoint Focus Notebook System, Intl. 230V ENGIncluding:- Notebook PC with Keypoint software- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017138 Catalog Number :

Device Description : "Keypoint Focus Notebook System, FRAIncluding:- Notebook PC with Keypoint softwa "Keypoint Focus Notebook System, FRAIncluding:- Notebook PC with Keypoint software, MS Office- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017145 Catalog Number :

Device Description : "Keypoint Focus Notebook System, DEUIncluding:- Notebook PC with Keypoint softwa "Keypoint Focus Notebook System, DEUIncluding:- Notebook PC with Keypoint software- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017152 Catalog Number :

Device Description : "Keypoint Focus Notebook System, SPAIncluding:- Notebook PC with Keypoint softwa "Keypoint Focus Notebook System, SPAIncluding:- Notebook PC with Keypoint software- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017169 Catalog Number :

Device Description : "Keypoint Focus Notebook System, NLDIncluding:- Notebook PC with Keypoint softwa "Keypoint Focus Notebook System, NLDIncluding:- Notebook PC with Keypoint software- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017176 Catalog Number :

Device Description : "Keypoint Focus Notebook System, ITAIncluding:- Notebook PC with Keypoint softwa "Keypoint Focus Notebook System, ITAIncluding:- Notebook PC with Keypoint software- Keypoint Focus Main unit with control panel, integrated speakers, EP stimulators- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017183 Catalog Number :

Device Description : "Keypoint Focus Notebook System, DANIncluding:- Notebook PC with Keypoint softwa "Keypoint Focus Notebook System, DANIncluding:- Notebook PC with Keypoint software- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017190 Catalog Number :

Device Description : Keypoint Focus Workstation, US/Canada 115V

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017206 Catalog Number :

Device Description : "Keypoint Focus Workstation, ENGIncluding:- USFF PC with Keypoint software, 22” "Keypoint Focus Workstation, ENGIncluding:- USFF PC with Keypoint software, 22” display- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- Cart with isolating power supply- System kit"

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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