510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060766Substantially Equivalent

Portable, Electrocardiograph (ECG) Monitor, Model Hcg-801

Omron Healthcare Co., Ltd., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060766 is the FDA 510(k) clearance record for PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801, a class II device, cleared for Omron Healthcare, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 68 510(k) clearances for Omron Healthcare, Inc., from to . As of , FDA records show no recalls naming K060766.

Clearance record

Decision date
Received
(79 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Omron Healthcare, Inc. 3460 Pt.e Creek Ct. #102, Bonita Springs FL
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