510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K123148Substantially Equivalent

Parace Md Ekoscope Is100

Parace, LLC, Yorktown Heights NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123148 is the FDA 510(k) clearance record for PARACE MD EKOSCOPE IS100, a class II device, cleared for Parace, LLC on under FDA product code DQD (Stethoscope, Electronic). FDA records list one 510(k) clearance for Parace, LLC. As of , FDA records show no recalls naming K123148.

Clearance record

Decision date
Received
(410 days to decision)
Product code
DQD Stethoscope, Electronic
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Applicant
Parace, LLC P.O. Box 171, Yorktown Heights NY
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