MICHELE SLEEP SCORING SYSTEM

GUDID B6005537160

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.

Cerebra Medical Ltd

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Primary Device IDB6005537160
NIH Device Record Key9670deea-4578-4e2c-9ccc-0064d249cd14
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICHELE SLEEP SCORING SYSTEM
Version Model Number1
Company DUNS203513726
Company NameCerebra Medical Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com
Phone18779493202
Emailinfo@michelesleepscoring.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB6005537160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNRVentilatory Effort Recorder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-11
Device Publish Date2018-02-12

Devices Manufactured by Cerebra Medical Ltd

B600700014 - Cerebra Sleep System2022-07-21 The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological sig
B6005537160 - MICHELE SLEEP SCORING SYSTEM2019-12-11The 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.
B6005537160 - MICHELE SLEEP SCORING SYSTEM2019-12-11 The MICHELE Sleep Scoring System is a Computer program (software) intended for use as an aid for the diagnosis of sleep and resp

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