510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
BZHClass II

Meter, Peak Flow, Spirometry

21 CFR 868.1860 / Anesthesiology
FDA source (opens on fda.gov)

BZH is the FDA product code for Meter, Peak Flow, Spirometry, a class II device type, regulated under 21 CFR 868.1860. As of , FDA records hold 81 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BZH
Device name
Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
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
81
Ingested recalls
0

Clearances, product code BZH

By decision year
81 clearances under product code BZH with a decision year between 1977 and 2026, 1996 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code BZH by decision year
YearClearances
19771
19781
19791
19811
19852
19902
19924
19934
19945
19954
199610
19974
19986
19993
20002
20012
20035
20041
20051
20061
20092
20102
20131
20141
20161
20171
20183
20191
20202
20211
20231
20243
20262

Applicants with the most clearances

Product code BZH
Applicants holding the most 510(k) clearances under product code BZH
ApplicantClearances
Monaghan Medical Corp.10
Clement Clarke Intl., Ltd.4
Enact Health Management Systems3
Health Products, Inc.3
Healthscan Products, Inc.3
Vitalograph, Inc.3
Beijing M&B Electronic Instruments Co., Ltd.2
Biotrine Corp.2
Card Guard Scientific Survival, Ltd.2
Clement Clarke, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order