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

Strap, Head, Gas Mask

21 CFR 868.5560 / Anesthesiology
FDA source (opens on fda.gov)

BTK is the FDA product code for Strap, Head, Gas Mask, a class I device type, regulated under 21 CFR 868.5560. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BTK
Device name
Strap, Head, Gas Mask
Regulation
21 CFR 868.5560
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
6
Ingested recalls
0

Clearances, product code BTK

By decision year
6 clearances under product code BTK with a decision year between 1981 and 1994, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code BTK by decision year
YearClearances
19811
19831
19852
19921
19941

Applicants with the most clearances

Product code BTK
Applicants holding the most 510(k) clearances under product code BTK
ApplicantClearances
Vital Signs, Inc.2
Life Design Systems, Inc.1
Medipart Jerry Alexander1
Medovations, Inc.1
Respironics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 91 companies shown, in name order