510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882319Substantially Equivalent

Telemetric Stethoscope

Vital Signs, Inc., Totowa NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882319 is the FDA 510(k) clearance record for TELEMETRIC STETHOSCOPE, a class II device, cleared for Vital Signs, Inc. on under FDA product code BZT (Stethoscope, Esophageal, With Electrical Conductors). FDA records list 75 510(k) clearances for Vital Signs, Inc., from to . As of , FDA records show no recalls naming K882319.

Clearance record

Decision date
Received
(57 days to decision)
Product code
BZT Stethoscope, Esophageal, With Electrical Conductors
Regulation
21 CFR 868.1920
Device class
Class II
Review panel
Anesthesiology
Applicant
Vital Signs, Inc. 20 Campus Rd., Totowa NJ
Third party review
No

Clearances, product code BZT

Trailing 12 months
1 clearance under product code BZT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260