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

Tent, Oxygen

21 CFR 868.5700 / Anesthesiology
FDA source (opens on fda.gov)

BYL is the FDA product code for Tent, Oxygen, a class I device type, regulated under 21 CFR 868.5700. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
BYL
Device name
Tent, Oxygen
Regulation
21 CFR 868.5700
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
11
Ingested recalls
1

Clearances, product code BYL

By decision year
11 clearances under product code BYL with a decision year between 1980 and 1994, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code BYL by decision year
YearClearances
19801
19821
19852
19881
19893
19901
19911
19941

Applicants with the most clearances

Product code BYL
Applicants holding the most 510(k) clearances under product code BYL
ApplicantClearances
Nascor Pty., Ltd.2
Viratek, Inc.2
Ann Arbor Plastics, Inc.1
Bird Products Corp.1
Dhd Medical Products Div. Diemolding Corp.1
Keystone Veterinary Supplies, Inc.1
Medicomp, Inc.1
Nova Health Systems, Inc.1
Safety Sea Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code