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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K932170
Device Name FLYNNR GENESIS II A/C, A/O AND IDLH
Applicant
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  CA L5S 1C8
Applicant Contact KEVIN BOWDEN
Correspondent
O-TWO SYSTEMS INTL., INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO,  CA L5S 1C8
Correspondent Contact KEVIN BOWDEN
Regulation Number868.5925
Classification Product Code
BTL  
Date Received05/04/1993
Decision Date 10/25/1993
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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