510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K021087Substantially Equivalent

Hippocrat Electronic Stethoscope, Model Dr300; Sounds Easy Auscultation Software

Erecords Limited, Toronto, CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021087 is the FDA 510(k) clearance record for HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE, a class II device, cleared for Erecords Limited on under FDA product code DQD (Stethoscope, Electronic). FDA records list one 510(k) clearance for Erecords Limited. As of , FDA records show no recalls naming K021087.

Clearance record

Decision date
Received
(191 days to decision)
Product code
DQD Stethoscope, Electronic
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Applicant
Erecords Limited 801 York Mills Rd., Toronto, CA
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