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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 K952327
Device Name SMARTSAT PULSE OXIMETRY ANALYZER
Applicant
Clinical Dynamics Corp.
121 N. Plains Industrial Rd.
Unit R
Wallingford,  CT  06492
Applicant Contact LEO F COSTELLO, JR.
Correspondent
Clinical Dynamics Corp.
121 N. Plains Industrial Rd.
Unit R
Wallingford,  CT  06492
Correspondent Contact LEO F COSTELLO, JR.
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/18/1995
Decision Date 08/25/1995
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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