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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K851889
Device Name CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
Applicant
Clinical Data, Inc.
1172 Commonwealth Ave.
Boston,  MA  02134
Applicant Contact ISRAEL M STEIN
Correspondent
Clinical Data, Inc.
1172 Commonwealth Ave.
Boston,  MA  02134
Correspondent Contact ISRAEL M STEIN
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/30/1985
Decision Date 10/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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