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

Monitor, Breathing Frequency

21 CFR 868.2375 / Anesthesiology
FDA source (opens on fda.gov)

BZQ is the FDA product code for Monitor, Breathing Frequency, a class II device type, regulated under 21 CFR 868.2375. As of , FDA records hold 176 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
BZQ
Device name
Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
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
176
Ingested recalls
3

Clearances, product code BZQ

By decision year
176 clearances under product code BZQ with a decision year between 1976 and 2026, 1986 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code BZQ by decision year
YearClearances
19762
19773
19782
19793
19804
198110
19826
19833
19844
19859
198615
198713
19887
19894
199011
19917
19925
19932
19947
19952
19962
19972
19985
19993
20002
20011
20041
20051
20072
20081
20093
20102
20111
20122
20133
20142
20162
20183
20191
20202
20212
20223
20231
20241
20257
20262

Applicants with the most clearances

Product code BZQ
Applicants holding the most 510(k) clearances under product code BZQ
ApplicantClearances
Aequitron Medical, Inc.9
Earlysense, Ltd.8
Healthdyne, Inc.8
Edentec Corp.6
GE Medical Systems Information Technologies, Inc.6
Braebon Medical Corp.4
Arvee Medical, Inc.3
Epm Information Systems, Inc.3
Gereonics, Inc.3
Honeywell, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 99 companies shown, in name order