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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
Optional accessory kit for use with SleepScout FDA UDI
Model / Reference
Optional Sensor Kit FDA UDI
Description
Optional accessory kit for use with SleepScout FDA UDI

Identifiers

Catalog Number
602-0051 FDA UDI
Primary DI / UDI-DI
B14360200511 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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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 a84b1def-b1af-48cc-851c-39ad4d3a507e 36 fields · synced May 30, 2026