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) (9) Electromyograph, Diagnostic (IKN) (9) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (9) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (9) Exerciser, Measuring (ISD) (1)

Premarket Exempt

No Yes

Clear

BioStamp nPoint™ - B493MC0003 Catalog Number :

Device Description : Exploratory Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B Exploratory Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05, B493MC0009

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493MC0004 Catalog Number :

Device Description : Discovery Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B49 Discovery Kit containing DIs B493BRCS02, B493BRCD01, B493BRCP01, B493BRCP02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05, B493MC0009

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493MC0005 Catalog Number :

Device Description : MC-0005 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

BioStamp nPoint™ - B493MC0006 Catalog Number :

Device Description : MC-0006 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

BioStamp nPoint™ - B493MC0007 Catalog Number :

Device Description : MC-0007 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493B MC-0007 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05

Device Class : 2

Duns Number: 829221139

Premarket Exempt : No

Product Code : MWI, LEL, IKN, DRG

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493MC0008 Catalog Number :

Device Description : MC-0008 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™ - B493MC0011 Catalog Number :

Device Description : MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493B MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC0009

Device Class : 2

Duns Number: 829221139

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

BioStamp nPoint™ - B493MC0012 Catalog Number :

Device Description : MC-0012 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

BioStamp nPoint™ - B493MC0013 Catalog Number :

Device Description : MC-0013 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

BioStamp nPoint™ - B493MC0014 Catalog Number :

Device Description : MC-0014 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493B MC-0014 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BRCT01, B493BSPS01, B493BRCA05

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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