Cleveland Medical Devices Inc.

Address:4415 EUCLID AVE,CLEVELAND,OH,44103,US

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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

Full-Montage Standard Electroencephalograph (GWQ) (10)

Premarket Exempt

Clear

SleepScout - B14350100280 Catalog Number : 501-0028

Device Description : SPO2 Interface cable for use with SleepScout PSG system

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

SleepScout - B14350101320 Catalog Number : 502-0132

Device Description : Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real t Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC.

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Sapphire - B143502012540 Catalog Number : 502-0125-4

Device Description : Wireless PSG Patient Unit for Sleep Testing

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Sapphire - B14350201440 Catalog Number : 502-0144

Device Description : SPO2 Interface cable for use with Sapphire PSG system

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

SleepScout - B143502014610 Catalog Number : 502-0146-1

Device Description : Wireless portable sleep monitor for sleep testing

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

SleepScout - B14350201490 Catalog Number : 502-0149

Device Description : SleepScout Computer Unit for recording/viewing SleepScout acquisition data in re SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC.

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

SleepView - B143502016910 Catalog Number : 502-0169-1

Device Description : Portable Sleep Monitor for Home Sleep Testing

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Sapphire - B14350201700 Catalog Number : 502-0170

Device Description : LifeSense Serial Interface cable for use with Sapphire PSG system

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

ReadyRip Belt - B143502020410 Catalog Number : 502-0204-1

Device Description : Single use, small respiratory belt.

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

ReadyRip Belt - B143502020420 Catalog Number : 502-0204-2

Device Description : Single use, medium respiratory belt.

Device Class :

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

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