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

Computer, Oxygen-Uptake

21 CFR 868.1730 / Anesthesiology
FDA source (opens on fda.gov)

BZL is the FDA product code for Computer, Oxygen-Uptake, a class II device type, regulated under 21 CFR 868.1730. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BZL
Device name
Computer, Oxygen-Uptake
Regulation
21 CFR 868.1730
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
33
Ingested recalls
0

Clearances, product code BZL

By decision year
33 clearances under product code BZL with a decision year between 1980 and 2020, 1982 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code BZL by decision year
YearClearances
19802
19824
19833
19862
19872
19881
19891
19902
19921
19932
19942
19971
20022
20031
20061
20072
20101
20111
20202

Applicants with the most clearances

Product code BZL
Applicants holding the most 510(k) clearances under product code BZL
ApplicantClearances
Medical Graphics Corp.4
Beckman Instruments, Inc.2
Datex Division Instrumentarium Corp.2
Healthetech, Inc.2
Icor AB2
Ametek/Thermox Instruments Division1
Columbus Instruments Intl. Corp.1
Cosmed Nordic ApS1
Cosmed S.r.l.1
Erich Jaeger, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order