510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091513Substantially Equivalent

Smart ECG Series Electrocardiograph, Models Se-3, Se-300A and 300B, Se-6, Se-600, Se-12, Se-12 Express and Se-1200

Edan Instruments, Inc., Yonkers NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091513 is the FDA 510(k) clearance record for SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200, a class II device, cleared for Edan Instruments, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 94 510(k) clearances for Edan Instruments, Inc., from to . As of , FDA records show one recall naming K091513.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Edan Instruments, Inc. 1 Odell Plz., Yonkers NY
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DPS

Trailing 12 months
5 clearances under product code DPS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260