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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K010739
Device Name WATCH-PAT 100
Applicant
Itamar Medical (C.M.) 1997 , Ltd.
377 Route 17
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Itamar Medical (C.M.) 1997 , Ltd.
377 Route 17
Hasbrouck Heights,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
JOM  
Date Received03/12/2001
Decision Date 11/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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