510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924054Substantially Equivalent

Phonocardiograph

Echo Ultrasound, Reedsville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924054 is the FDA 510(k) clearance record for PHONOCARDIOGRAPH, a class I device, cleared for Echo Ultrasound on under FDA product code DQC (Phonocardiograph). FDA records list 6 510(k) clearances for Echo Ultrasound, from to . As of , FDA records show no recalls naming K924054.

Clearance record

Decision date
Received
(163 days to decision)
Product code
DQC Phonocardiograph
Regulation
21 CFR 870.2390
Device class
Class I
Review panel
Cardiovascular
Applicant
Echo Ultrasound R.D. 2, Box 118, Reedsville PA
510(k) summary
Summary
Third party review
No

Clearances, product code DQC

Trailing 12 months

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

FDA records show no clearances under product code DQC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DQC, 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