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

Flowmeter, Calibration, Gas

21 CFR 868.2350 / Anesthesiology
FDA source (opens on fda.gov)

BXY is the FDA product code for Flowmeter, Calibration, Gas, a class I device type, regulated under 21 CFR 868.2350. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BXY
Device name
Flowmeter, Calibration, Gas
Regulation
21 CFR 868.2350
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
7
Ingested recalls
0

Clearances, product code BXY

By decision year
7 clearances under product code BXY with a decision year between 1978 and 1995, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code BXY by decision year
YearClearances
19781
19851
19862
19902
19951

Applicants with the most clearances

Product code BXY
Applicants holding the most 510(k) clearances under product code BXY
ApplicantClearances
Precision Medical, Inc.2
B & B Medical Technologies, Inc.1
Gardner Cryogenics1
Life Support Products, Inc.1
Telectronics, Inc.1
Westmed Intl.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order