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

Analyzer, Gas, Helium, Gaseous-Phase

21 CFR 868.1640 / Anesthesiology
FDA source (opens on fda.gov)

BSE is the FDA product code for Analyzer, Gas, Helium, Gaseous-Phase, a class II device type, regulated under 21 CFR 868.1640. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BSE
Device name
Analyzer, Gas, Helium, Gaseous-Phase
Regulation
21 CFR 868.1640
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code BSE

By decision year
3 clearances under product code BSE with a decision year between 1984 and 1991, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code BSE by decision year
YearClearances
19842
19911

Applicants with the most clearances

Product code BSE
Applicants holding the most 510(k) clearances under product code BSE
ApplicantClearances
Datamed, Inc.1
Erich Jaeger, Inc.1
Medical Associated Services, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code