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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
Recalls CDRH Recalls
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