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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K032971
Device Name TIDAL WAVE SP MODEL 710/715 AND 715
Applicant
Respironics Novametrix, Inc.
5 Technology Dr.
Wallingford,  CT  06492
Applicant Contact MICHAEL J MALIS
Correspondent
Respironics Novametrix, Inc.
5 Technology Dr.
Wallingford,  CT  06492
Correspondent Contact MICHAEL J MALIS
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/22/2003
Decision Date 08/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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