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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 K081037
Device Name WATCH-PAT 200I (WP200I)
Applicant
ITAMAR MEDICAL
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact JOHATHAN S KAHAN
Correspondent
ITAMAR MEDICAL
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact JOHATHAN S KAHAN
Regulation Number868.2375
Classification Product Code
MNR  
Date Received04/11/2008
Decision Date 06/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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