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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K882352
Device Name MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.
Applicant
Clinical Information Systems, Inc.
1120 N. Wagner Rd.
Ann Arbor,  MI  48103
Applicant Contact DOUGLAS KASSAB
Correspondent
Clinical Information Systems, Inc.
1120 N. Wagner Rd.
Ann Arbor,  MI  48103
Correspondent Contact DOUGLAS KASSAB
Regulation Number868.1720
Classification Product Code
CCL  
Date Received06/07/1988
Decision Date 11/02/1988
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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