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

Stethoscope, Esophageal, With Electrical Conductors

21 CFR 868.1920 / Anesthesiology
FDA source (opens on fda.gov)

BZT is the FDA product code for Stethoscope, Esophageal, With Electrical Conductors, a class II device type, regulated under 21 CFR 868.1920. As of , FDA records hold 46 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
BZT
Device name
Stethoscope, Esophageal, With Electrical Conductors
Regulation
21 CFR 868.1920
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
46
Ingested recalls
4

Clearances, product code BZT

By decision year
46 clearances under product code BZT with a decision year between 1979 and 2025, 1986 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code BZT by decision year
YearClearances
19791
19814
19821
19832
19844
19851
19866
19874
19882
19893
19911
19921
19932
19942
19952
19961
19982
20061
20071
20091
20121
20141
20201
20251

Applicants with the most clearances

Product code BZT
Applicants holding the most 510(k) clearances under product code BZT
ApplicantClearances
Sheridan Catheter Corp.4
DeRoyal Industries, Inc.3
Biomedical Concepts, Inc.2
Coast Medical Corp.2
Abbott Medical2
Respiratory Support Products, Inc.2
Sensortek, Inc.2
Starboard Medical, Inc.2
Vitacomm, Inc.2
Yellow Springs Instrument Co., Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order