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SleepScout

FDA UDI

Class II (US FDA UDI)

by Cleveland Medical Devices Inc.

Identity

Trade Name
SleepScout FDA UDI
Generic Name
Electroencephalograph FDA UDI
Device Name
Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC. FDA UDI
Model / Reference
Computer Unit FDA UDI
Description
Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC. FDA UDI

Identifiers

Catalog Number
502-0132 FDA UDI
Primary DI / UDI-DI
B14350101320 FDA UDI
510(k) Number
K042039 FDA UDI
FDA Product Code
GWQ FDA UDI
GMDN Term
Electroencephalograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

SleepScout by Cleveland Medical Devices Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K042039 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cleveland Medical Devices Inc.

Sources (1)

  • FDA UDI 99ead404-842b-4288-b335-ac6d9c45b27e 36 fields · synced May 30, 2026