510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K120188Substantially Equivalent

Electrocardiograph

Edan Instruments, Inc., Shenzhen, CN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120188 is the FDA 510(k) clearance record for ELECTROCARDIOGRAPH, 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 no recalls naming K120188.

Clearance record

Decision date
Received
(53 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Edan Instruments, Inc. 3/F-B, Nanshan Medical, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPS

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