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

Analyzer, Gas, Water Vapor, Gaseous-Phase

21 CFR 868.1975 / Anesthesiology
FDA source (opens on fda.gov)

BXA is the FDA product code for Analyzer, Gas, Water Vapor, Gaseous-Phase, a class I device type, regulated under 21 CFR 868.1975. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BXA
Device name
Analyzer, Gas, Water Vapor, Gaseous-Phase
Regulation
21 CFR 868.1975
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
0

Clearances, product code BXA

By decision year
2 clearances under product code BXA with a decision year between 1976 and 1977, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code BXA by decision year
YearClearances
19761
19771

Applicants with the most clearances

Product code BXA
Applicants holding the most 510(k) clearances under product code BXA
ApplicantClearances
Isothermal Systems, Inc.1
Sherwood Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code