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

Set, Tubing And Support, Ventilator (W Harness)

21 CFR 868.5975 / Anesthesiology
FDA source (opens on fda.gov)

BZO is the FDA product code for Set, Tubing And Support, Ventilator (W Harness), a class I device type, regulated under 21 CFR 868.5975. As of , FDA records hold 88 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
BZO
Device name
Set, Tubing And Support, Ventilator (W Harness)
Regulation
21 CFR 868.5975
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
88
Ingested recalls
23

Clearances, product code BZO

By decision year
88 clearances under product code BZO with a decision year between 1976 and 1995, 1984 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code BZO by decision year
YearClearances
19761
19774
19798
19802
19815
19828
19834
198410
19854
19867
19873
19884
19894
19904
19911
19922
19936
19944
19957

Applicants with the most clearances

Product code BZO
Applicants holding the most 510(k) clearances under product code BZO
ApplicantClearances
Airlife, Inc.5
Prima, Inc.5
Nova-Ventrx4
Cygnus Research Corp.3
Dryden Corp.3
Avatron, Inc.2
Dhd Medical Products Div. Diemolding Corp.2
Hudson Oxygen Therapy Sales Co.2
Infrasonics Corp.2
Intertech Resources, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 142 companies shown, in name order