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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 K893643
Device Name NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
Applicant
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Applicant Contact H SCHIFFMAN
Correspondent
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Correspondent Contact H SCHIFFMAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/15/1989
Decision Date 10/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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