510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950537Substantially Equivalent

Cardiophonics Incorporated Dps 2000 Phonocardiograph

Cardiophonics, Inc., Port Jefferson Station NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950537 is the FDA 510(k) clearance record for CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH, a class I device, cleared for Cardiophonics, Inc. on under FDA product code DQC (Phonocardiograph). FDA records list one 510(k) clearance for Cardiophonics, Inc. As of , FDA records show no recalls naming K950537.

Clearance record

Decision date
Received
(388 days to decision)
Product code
DQC Phonocardiograph
Regulation
21 CFR 870.2390
Device class
Class I
Review panel
Cardiovascular
Applicant
Cardiophonics, Inc. 1 Ken Pl., Port Jefferson Station NY
510(k) summary
Statement
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