510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K162665Substantially Equivalent

MiCor A100 Wearable ECG Recorder

Mitac International Corp., Taoyuan City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162665 is the FDA 510(k) clearance record for MiCor A100 Wearable ECG Recorder, a class II device, cleared for Mitac International Corp. on under FDA product code DPS (Electrocardiograph). FDA records list one 510(k) clearance for Mitac International Corp. As of , FDA records show no recalls naming K162665.

Clearance record

Decision date
Received
(487 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Mitac International Corp. # 200, Wen Hua 2nd Rd., Guishan Dist., Taoyuan City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPS

Trailing 12 months
7 clearances under product code DPS in the twelve months to October 2026, September 2026 the highest month at 2.
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 20262
October 20261