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 - 05704736017213 Catalog Number :

Device Description : Keypoint Focus Workstation, French-Canadian 115V

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine BioMed - 05704736017220 Catalog Number :

Device Description : "Keypoint Focus Workstation, Intl. 115V (ENG)Including:- USFF PC with Keypoint s "Keypoint Focus Workstation, Intl. 115V (ENG)Including:- 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

Alpine BioMed - 05704736017237 Catalog Number :

Device Description : "Keypoint Focus Workstation, Intl. 230V (ENG)Including:- USFF PC with Keypoint s "Keypoint Focus Workstation, Intl. 230V (ENG)Including:- 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

Alpine BioMed - 05704736017244 Catalog Number :

Device Description : "Keypoint Focus Workstation, FRAIncluding:- USFF PC with Keypoint software, MS O "Keypoint Focus Workstation, FRAIncluding:- USFF PC with Keypoint software, MS Office, 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

Alpine BioMed - 05704736017251 Catalog Number :

Device Description : "Keypoint Focus Workstation, DEUIncluding:- USFF PC with Keypoint software, 22” "Keypoint Focus Workstation, DEUIncluding:- 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

Alpine BioMed - 05704736017268 Catalog Number :

Device Description : "Keypoint Focus Workstation, SPAIncluding:- USFF PC with Keypoint software, 22” "Keypoint Focus Workstation, SPAIncluding:- 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

Alpine BioMed - 05704736017275 Catalog Number :

Device Description : "Keypoint Focus Workstation, NLDIncluding:- USFF PC with Keypoint software, 22” "Keypoint Focus Workstation, NLDIncluding:- 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

Alpine BioMed - 05704736017282 Catalog Number :

Device Description : "Keypoint Focus Workstation, ITAIncluding:- USFF PC with Keypoint software, 22” "Keypoint Focus Workstation, ITAIncluding:- 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

Alpine BioMed - 05704736017381 Catalog Number :

Device Description : Keypoint G4, French-Canadian 115V

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Alpine Biomed - 05704736017558 Catalog Number :

Device Description : Hand-Held Stimulating Electrodes

Device Class : 2

Duns Number: 311231554

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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