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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 K982776
Device Name 9303 NEONATAL/ADULT VITAL SIGNS MONITOR
Applicant
CAS MEDICAL SYSTEMS, INC.
21 BUSINESS PARK DR.
BRANFORD,  CT  06405
Applicant Contact RON JEFFREY
Correspondent
CAS MEDICAL SYSTEMS, INC.
21 BUSINESS PARK DR.
BRANFORD,  CT  06405
Correspondent Contact RON JEFFREY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/06/1998
Decision Date 11/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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