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

Stethoscope, Esophageal

21 CFR 868.1910 / Anesthesiology
FDA source (opens on fda.gov)

BZW is the FDA product code for Stethoscope, Esophageal, a class I device type, regulated under 21 CFR 868.1910. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BZW
Device name
Stethoscope, Esophageal
Regulation
21 CFR 868.1910
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
13
Ingested recalls
0

Clearances, product code BZW

By decision year
13 clearances under product code BZW with a decision year between 1977 and 1988, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code BZW by decision year
YearClearances
19771
19791
19801
19821
19833
19843
19851
19861
19881

Applicants with the most clearances

Product code BZW
Applicants holding the most 510(k) clearances under product code BZW
ApplicantClearances
Axiom Medical, Inc.1
Electromedics, Inc.1
Inmed Corp.1
Labarge, Inc.1
Medical Components, Inc.1
Medical Parameters, Inc.1
Mon-A-Therm, Inc.1
Primrose Medical, Inc.1
Rsp, Inc.1
Science Development Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order