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

Tent, Oxygen, Electrically Powered

21 CFR 868.5710 / Anesthesiology
FDA source (opens on fda.gov)

BYK is the FDA product code for Tent, Oxygen, Electrically Powered, a class II device type, regulated under 21 CFR 868.5710. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BYK
Device name
Tent, Oxygen, Electrically Powered
Regulation
21 CFR 868.5710
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code BYK

By decision year
3 clearances under product code BYK with a decision year between 1981 and 1995, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code BYK by decision year
YearClearances
19811
19881
19951

Applicants with the most clearances

Product code BYK
Applicants holding the most 510(k) clearances under product code BYK
ApplicantClearances
Allied Medical LLC1
Swisco, Inc.1
Timeter Instrument Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code