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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K940712
Device Name PPM III
Applicant
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST., UNIT 5
MISSISSAUGA
ONTARIO L5S 1C8,  CA
Applicant Contact KEVIN BOWDEN
Correspondent
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST., UNIT 5
MISSISSAUGA
ONTARIO L5S 1C8,  CA
Correspondent Contact KEVIN BOWDEN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received02/17/1994
Decision Date 11/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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