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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 K884891
Device Name OC-100 OXIMETER INTERFACE CALIBRATOR
Applicant
Telediagnostic Systems, Inc.
2053 Sutter St.
San Francisco,  CA  94115
Applicant Contact LARRY WOODARD
Correspondent
Telediagnostic Systems, Inc.
2053 Sutter St.
San Francisco,  CA  94115
Correspondent Contact LARRY WOODARD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/22/1988
Decision Date 12/28/1988
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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