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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K931355
Device Name WHISPER O2
Applicant
Trilogic Corp.
8175 Grant Way
Littleton,  CO  80122
Applicant Contact DAVE AUBURN
Correspondent
Trilogic Corp.
8175 Grant Way
Littleton,  CO  80122
Correspondent Contact DAVE AUBURN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/17/1993
Decision Date 03/25/1994
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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