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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 K880756
Device Name MODEL PM-20A PHYSIOLOGICAL MONITOR
Applicant
Advanced Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact ANTHONY CALDERONI
Correspondent
Advanced Medical Systems, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact ANTHONY CALDERONI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/25/1988
Decision Date 09/27/1988
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
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