510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090936Substantially Equivalent

Single-Channel Handheld Electrocardiograph, Model Ecg80a

Contec Medical System Co., Ltd., Zhong Shan, Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090936 is the FDA 510(k) clearance record for SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A, a class II device, cleared for Contec Medical System Co., Ltd. on under FDA product code DPS (Electrocardiograph). FDA records list 12 510(k) clearances for Contec Medical System Co., Ltd., from to . As of , FDA records show no recalls naming K090936.

Clearance record

Decision date
Received
(145 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Contec Medical System Co., Ltd. Suite 8d, Zhongxin Zhongshan, Zhong Shan, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

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