510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935146Substantially Equivalent

Disposable Stethoscope Head Cover

Modern Medical Devices, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935146 is the FDA 510(k) clearance record for DISPOSABLE STETHOSCOPE HEAD COVER, a class I device, cleared for Modern Medical Devices, Inc. on under FDA product code BZS (Stethoscope Head). FDA records list one 510(k) clearance for Modern Medical Devices, Inc. As of , FDA records show no recalls naming K935146.

Clearance record

Decision date
Received
(256 days to decision)
Product code
BZS Stethoscope Head
Regulation
21 CFR 868.1930
Device class
Class I
Review panel
Anesthesiology
Applicant
Modern Medical Devices, Inc. 42307 Osgood Rd. Suite N, Fremont CA
510(k) summary
Summary
Third party review
No

Clearances, product code BZS

Trailing 12 months

FDA records hold no clearances under product code BZS in the trailing twelve months.

FDA records show no clearances under product code BZS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260