510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230265Substantially Equivalent

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

Infobionic, Inc., Chelmsford MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230265 is the FDA 510(k) clearance record for MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System, a class II device, cleared for Infobionic, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 5 510(k) clearances for Infobionic, Inc., from to . As of , FDA records show no recalls naming K230265.

Clearance record

Decision date
Received
(248 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Infobionic, Inc. 312 Billerica Rd. Office Link #5, Chelmsford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260