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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 K983500
Device Name PRO2 CHECK OXYGEN INDICATOR
Applicant
Medical Technology Specialists, Inc.
6290-D Warwick Rd.
Richmond,  VA  23224
Applicant Contact DONALD W MORROW, III
Correspondent
Medical Technology Specialists, Inc.
6290-D Warwick Rd.
Richmond,  VA  23224
Correspondent Contact DONALD W MORROW, III
Regulation Number868.1720
Classification Product Code
CCL  
Date Received10/06/1998
Decision Date 03/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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