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

Device, Biofeedback (HCC) (4) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (4) Transducer, Ultrasonic, Diagnostic (ITX) (4) Perineometer (HIR) (1) Uroflowmeter (EXY) (1)

Premarket Exempt

No Yes

Clear

Pathway - 00852423006202 Catalog Number : 6320

Device Description : Pathway® 6320 Vaginal/Rectal EMG Sensor

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : HIR

Prescription Use : Yes

Device Count : 1

N/A - 00852423006219 Catalog Number : 5328

Device Description : 24” Electrode Lead Wire Set

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

N/A - 00852423006226 Catalog Number : 5338

Device Description : 6’ Electrode Lead Wire Set

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006233 Catalog Number : 3660

Device Description : Pathway® Adapter

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

N/A - 00852423006240 Catalog Number : 7100

Device Description : Adapter for 7400 Disposable Lead Wire Electrodes

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

N/A - 00852423006301 Catalog Number : WLC

Device Description : Uroflowmetry Load Cell

Device Class : 2

Duns Number: 625863568

Premarket Exempt : Yes

Product Code : EXY

Prescription Use : Yes

Device Count : 1

Morpheus - 00852423006318 Catalog Number : N/A

Device Description : Morpheus® Control Module

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

Quickscan - 00852423006325 Catalog Number : QSBU

Device Description : Quickscan® Bladder Ultrasound Imaging

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

Pathway - 00852423006332 Catalog Number : N/A

Device Description : Pathway® RealTime Ultrasound

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

Morpheus® - 00852423006349 Catalog Number : RTTV

Device Description : 5-12 MHz 90° Endovaginal Ultrasound Imaging

Device Class : 2

Duns Number: 625863568

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

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