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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K874559
Device Name BABYFLEX PATIENT CIRCUIT
Applicant
AIROFLEX MEDICAL, INC.
ATTORNEY AT LAW
2085 RUSTIN AVENUE
RIVERSIDE,  CA  92507
Applicant Contact STANLEY E FRY
Correspondent
AIROFLEX MEDICAL, INC.
ATTORNEY AT LAW
2085 RUSTIN AVENUE
RIVERSIDE,  CA  92507
Correspondent Contact STANLEY E FRY
Regulation Number868.5975
Classification Product Code
BZO  
Date Received11/04/1987
Decision Date 12/21/1987
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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