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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
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