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

Device, Rebreathing

21 CFR 868.5675 / Anesthesiology
FDA source (opens on fda.gov)

BYW is the FDA product code for Device, Rebreathing, a class I device type, regulated under 21 CFR 868.5675. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
BYW
Device name
Device, Rebreathing
Regulation
21 CFR 868.5675
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
2
Ingested recalls
1

Clearances, product code BYW

By decision year
2 clearances under product code BYW with a decision year between 1980 and 1990, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code BYW by decision year
YearClearances
19801
19901

Applicants with the most clearances

Product code BYW
Applicants holding the most 510(k) clearances under product code BYW
ApplicantClearances
Global Business, Inc.1
Sherwood Medical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order