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

Calculator, Pulmonary Function Data

21 CFR 868.1880 / Anesthesiology
FDA source (opens on fda.gov)

BZC is the FDA product code for Calculator, Pulmonary Function Data, a class II device type, regulated under 21 CFR 868.1880. As of , FDA records hold 90 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
BZC
Device name
Calculator, Pulmonary Function Data
Regulation
21 CFR 868.1880
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
90
Ingested recalls
5

Clearances, product code BZC

By decision year
90 clearances under product code BZC with a decision year between 1977 and 2024, 1980 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code BZC by decision year
YearClearances
19771
19782
19792
198010
19816
19821
19834
19846
19852
19865
19881
19896
19902
19911
19923
19931
19941
19955
19963
19977
19982
20002
20012
20021
20031
20041
20051
20071
20111
20142
20151
20161
20171
20181
20192
20241

Applicants with the most clearances

Product code BZC
Applicants holding the most 510(k) clearances under product code BZC
ApplicantClearances
Erich Jaeger, Inc.8
Novametrix Medical Systems, Inc.4
Warren E. Collins, Inc.4
Cardio Pulmonary Instruments3
Cosmed S.r.l.3
Cybermedic, Inc.3
P.K. Morgan, Ltd.3
Pulmonary Testing Systems3
Jaeger Medical GmbH3
Carefusion Germany 234 GmbH2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order