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Michele Sleep Scoring System

FDA UDI

Class II (US FDA UDI)

by Cerebra Medical , Ltd.

Identity

Trade Name
MICHELE SLEEP SCORING SYSTEM FDA UDI
Generic Name
Sleep disorder interpretive software, professional-only FDA UDI
Device Name
The MICHELE Sleep Scoring System is a Computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients. FDA UDI
Model / Reference
1 FDA UDI
Description
The MICHELE Sleep Scoring System is a Computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients. FDA UDI

Identifiers

Primary DI / UDI-DI
B6005537160 FDA UDI
510(k) Number
K112102 FDA UDI
FDA Product Code
MNR FDA UDI
GMDN Term
Sleep disorder interpretive software, professional-only FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sleep disorder interpretive software, professional-only

Michele Sleep Scoring System by Cerebra Medical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sleep disorder interpretive software, professional-only.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cerebra Medical , Ltd.

Sources (1)

  • FDA UDI 9670deea-4578-4e2c-9ccc-0064d249cd14 35 fields · synced Jun 1, 2026