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

Algesimeter, Manual

21 CFR 868.1030 / Anesthesiology
FDA source (opens on fda.gov)

BXL is the FDA product code for Algesimeter, Manual, a class I device type, regulated under 21 CFR 868.1030. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
BXL
Device name
Algesimeter, Manual
Regulation
21 CFR 868.1030
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code BXL

By decision year
1 clearance under product code BXL with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code BXL by decision year
YearClearances
19831

Applicants with the most clearances

Product code BXL
Applicants holding the most 510(k) clearances under product code BXL
ApplicantClearances
Catalyst Research Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code