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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, Enflurane, Gaseous-Phase (Anesthetic Concentration)
510(k) Number K902021
Device Name RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
Applicant
Albion Instruments
4745 Wiley Post Way,650 Plz.
6
Salt Lake City,  UT  84116
Applicant Contact HIBDON, MS
Correspondent
Albion Instruments
4745 Wiley Post Way,650 Plz.
6
Salt Lake City,  UT  84116
Correspondent Contact HIBDON, MS
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received05/03/1990
Decision Date 10/09/1990
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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