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

Meter, Airway Pressure (Inspiratory Force)

21 CFR 868.1780 / Anesthesiology
FDA source (opens on fda.gov)

BXR is the FDA product code for Meter, Airway Pressure (Inspiratory Force), a class II device type, regulated under 21 CFR 868.1780. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BXR
Device name
Meter, Airway Pressure (Inspiratory Force)
Regulation
21 CFR 868.1780
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
6
Ingested recalls
0

Clearances, product code BXR

By decision year
6 clearances under product code BXR with a decision year between 1988 and 2008, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code BXR by decision year
YearClearances
19881
19901
19911
19921
20041
20081

Applicants with the most clearances

Product code BXR
Applicants holding the most 510(k) clearances under product code BXR
ApplicantClearances
Dhd Medical Products Div. Diemolding Corp.1
Instrumentation Industries, Incorporated1
Medical Support Products, Inc.1
Mercury Medical1
Thayer Medical Corportation1
Warren E. Collins, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code