PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

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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

Perineometer (HIR) (4) Stimulator, Electrical, Non-Implantable, For Incontinence (KPI) (3) Device, Biofeedback (HCC) (2) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1) Uroflowmeter (EXY) (1)

Premarket Exempt

No Yes

Clear

Morpheus - 00852423006004 Catalog Number : MOR0118

Device Description : Morpheus® Control Module

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : ITX, IYO, KPI

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006011 Catalog Number : CTS2000

Device Description : Pathway® CTS 2000

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006028 Catalog Number : CTS1500

Device Description : Pathway® CTS 1500

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006035 Catalog Number : PDUO

Device Description : Pathway® DUO for Pediatric Voiding Dysfunction

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : EXY

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006042 Catalog Number : 9725

Device Description : Pathway® MR-25 Dual Channel EMG

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : HIR

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006059 Catalog Number : 9710

Device Description : Pathway® MR-20 Dual Channel EMG

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : HIR

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006066 Catalog Number : 9715

Device Description : Pathway® MR-15 Single Channel EMG

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : HIR

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006073 Catalog Number : 9700

Device Description : Pathway® MR-10 Single Channel EMG

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : HIR

Prescription Use : Yes

Device Count : 1

Telesis - 00852423006080 Catalog Number : 9250

Device Description : Telesis® Software for the Pathway® MR Series

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Primus - 00852423006097 Catalog Number : 9275

Device Description : Primus® Software for the Pathway® MR Series

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

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