510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K110328Substantially Equivalent

Acg-8511 Portable ECG Monitor

Andon Health Co., Ltd, Tianjin, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110328 is the FDA 510(k) clearance record for ACG-8511 PORTABLE ECG MONITOR, a class II device, cleared for Andon Health Co, Ltd. on under FDA product code DPS (Electrocardiograph). FDA records list 92 510(k) clearances for Andon Health Co, Ltd., from to . As of , FDA records show no recalls naming K110328.

Clearance record

Decision date
Received
(162 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Andon Health Co, Ltd. No 3, Jin Ping St., Ya An Rd., Tianjin, CN
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 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 20262
November 20260