510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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BYFClass I

Mask, Oxygen, Low Concentration, Venturi

21 CFR 868.5600 / Anesthesiology
FDA source (opens on fda.gov)

BYF is the FDA product code for Mask, Oxygen, Low Concentration, Venturi, a class I device type, regulated under 21 CFR 868.5600. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
BYF
Device name
Mask, Oxygen, Low Concentration, Venturi
Regulation
21 CFR 868.5600
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
19
Ingested recalls
3

Clearances, product code BYF

By decision year
19 clearances under product code BYF with a decision year between 1976 and 1996, 1981 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code BYF by decision year
YearClearances
19761
19771
19784
19791
19815
19831
19851
19862
19891
19951
19961

Applicants with the most clearances

Product code BYF
Applicants holding the most 510(k) clearances under product code BYF
ApplicantClearances
Airlife, Inc.5
Dhd Medical Products Div. Diemolding Corp.2
Hospitak, Inc.2
Todd Industries, Inc.2
Ashai Co., Ltd.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Dadsun Corp., Ltd.1
Flexicare Medical Ltd.1
Landmark Plastics1
Respiratory Care, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 90 companies shown, in name order