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

Premium Study Kit - B14360201111 Catalog Number : 602-0111

Device Description : Single use, premium study kit extra large.

Device Class :

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Premium Study Kit - B14360201141 Catalog Number : 602-0114

Device Description : Single use, premium study kit extra extra large.

Device Class :

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Study Kit - B14360201171 Catalog Number : 602-0117

Device Description : Single use international study kit.

Device Class :

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Premium Study Kit - B14360201201 Catalog Number : 602-0120

Device Description : Single use, premium study kit with two large ReadyRip Belts

Device Class :

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Premium Study Kit - B14360201231 Catalog Number : 602-0123

Device Description : Single use, premium study kit with two Xlarge ReadyRip Belts

Device Class :

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Premium Study Kit - B14360201261 Catalog Number : 602-0123

Device Description : Single use, premium study kit with two XXlarge ReadyRip Belts

Device Class :

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

SleepScout - B14360201292 Catalog Number : 602-0129

Device Description : Optional accessory kit for use with SleepScout - International customers

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

SleepScout Starter Kit - B143700000712 Catalog Number : 700-0007-1

Device Description : SleepScout Starter Kit

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Sapphire PSG 2400 Starter Kit - B143700000922 Catalog Number : 700-0009-2

Device Description : Sapphire PSG 2400 Starter Kit.

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

SleepView Starter Kit - B1437000011102 Catalog Number : 700-0011-10

Device Description : SleepView Rental Starter Kit including 15 premium study kits

Device Class : 2

Duns Number: 557510625

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

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