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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K895082
Device Name VOYAGER PX
Applicant
Smith-Perry Corp.
275 W. 10th St.
Riviera Beach,  FL  33404
Applicant Contact DAVID SMITH
Correspondent
Smith-Perry Corp.
275 W. 10th St.
Riviera Beach,  FL  33404
Correspondent Contact DAVID SMITH
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received08/14/1989
Decision Date 01/09/1990
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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