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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 St., NW
Washington, Dc,  DC  20004
Applicant Contact JOHATHAN S KAHAN
Correspondent
Itamar Medical
555 Thirteenth St., NW
Washington, Dc,  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
Predetermined Change
Control Plan Authorized		 No
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