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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K920622
Device Name RASCAL II
Applicant
Ohmeda Medical
4745 Wiley Post Way,650 Plaza
6
Salt Lake City,  UT  84116
Applicant Contact DWIGHT HIBDON
Correspondent
Ohmeda Medical
4745 Wiley Post Way,650 Plaza
6
Salt Lake City,  UT  84116
Correspondent Contact DWIGHT HIBDON
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/11/1992
Decision Date 10/13/1992
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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