510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K111160Substantially Equivalent

Intricon Datrix Centauri Mt Ambulatory Patient ECG Telemetry System (Apets)

Intricon Datrix Corporation, Appollo Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111160 is the FDA 510(k) clearance record for INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS), a class II device, cleared for Intricon Datrix Corporation on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 2 510(k) clearances for Intricon Datrix Corporation, from to . As of , FDA records show no recalls naming K111160.

Clearance record

Decision date
Received
(98 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Intricon Datrix Corporation 962 Allegro Ln., Appollo Beach FL
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