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) (5) Electromyograph, Diagnostic (IKN) (5) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (5) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (5) Exerciser, Measuring (ISD) (3)

Premarket Exempt

No Yes

Clear

BioStamp nPoint™ - B493MC0015 Catalog Number :

Device Description : MC-0015 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

Kintinuum™ - B493MC0016 Catalog Number :

Device Description : Instructions for use

Device Class : 2

Duns Number: 829221139

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493SW0025 Catalog Number :

Device Description : Link application for Android

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493SW0026 Catalog Number :

Device Description : Sync application for Android

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493SW0027 Catalog Number :

Device Description : Investigator application for Android

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493SW0028 Catalog Number :

Device Description : Web application

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

Kintinuum™ - B493SW0042 Catalog Number :

Device Description : Patient application for Android

Device Class : 2

Duns Number: 829221139

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Kintinuum™ - B493SW0043 Catalog Number :

Device Description : Web application

Device Class : 2

Duns Number: 829221139

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

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