510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K230769Substantially Equivalent

PrevisEA Device

Entac Medical, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230769 is the FDA 510(k) clearance record for PrevisEA Device, a class II device, cleared for Entac Medical, Inc. on under FDA product code DQD (Stethoscope, Electronic). FDA records list 2 510(k) clearances for Entac Medical, Inc., from to . As of , FDA records show no recalls naming K230769.

Clearance record

Decision date
Received
(60 days to decision)
Product code
DQD Stethoscope, Electronic
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Applicant
Entac Medical, Inc. 680 Oalkleaf Office Lance, Suite 201, Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQD

Trailing 12 months
6 clearances under product code DQD in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DQD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20262
August 20260
September 20260
October 20260