MC10, INC.

MC10, INC.

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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

Device, Sleep Assessment (LEL) (10) Electromyograph, Diagnostic (IKN) (10) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (10) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (10)

Premarket Exempt

No Yes

Clear

BioStamp® - B493BRCA02 Catalog Number :

Device Description : Adhesive with hydrogel

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - B493BRCA05 Catalog Number :

Device Description : Adhesive applicator

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493BRCD01 Catalog Number :

Device Description : Link Hub smart charger

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - B493BRCD02 Catalog Number :

Device Description : Link Hub smart charger

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493BRCP01 Catalog Number :

Device Description : Mobile application phone

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493BRCP02 Catalog Number :

Device Description : Mobile application phone

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - B493BRCP03 Catalog Number :

Device Description : Mobile application phone

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - B493BRCS02 Catalog Number :

Device Description : Wearable sensor patch

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493BRCT01 Catalog Number :

Device Description : Mobile application tablet

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp® - B493BSPS01 Catalog Number :

Device Description : Link Hub smart charger power supply

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

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