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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, Halothane, Gaseous-Phase (Anesthetic Conc.)
510(k) Number K951366
Device Name RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)
Applicant
Riken Keiki Co., Ltd.
12318 Big Tree Rd.
Wales Center,  NY  14169
Applicant Contact ALLAN M BICKFORD
Correspondent
Riken Keiki Co., Ltd.
12318 Big Tree Rd.
Wales Center,  NY  14169
Correspondent Contact ALLAN M BICKFORD
Regulation Number868.1620
Classification Product Code
CBS  
Date Received03/27/1995
Decision Date 08/02/1995
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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