MWJClass II

Electrocardiograph, Ambulatory (Without Analysis)

21 CFR 870.2800 / Cardiovascular

MWJ is the FDA product code for Electrocardiograph, Ambulatory (Without Analysis), a class II device type, regulated under 21 CFR 870.2800. As of 2026-09-10, FDA records hold 62 510(k) clearances under this code, the most recent dated 2026-08-14, and 5 recalls.

Classification record

Product code: MWJ
Device name: Electrocardiograph, Ambulatory (Without Analysis)
Regulation: 21 CFR 870.2800
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 64
Ingested recalls: 5

Clearances, product code MWJ

By decision year

64 clearances under product code MWJ with a decision year between 1998 and 2026, 2000 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code MWJ by decision year
Year	Clearances
1998	2
1999	5
2000	6
2001	2
2002	2
2003	4
2004	3
2005	3
2006	2
2007	5
2008	1
2009	2
2010	3
2011	3
2012	1
2013	3
2014	2
2016	2
2018	1
2021	1
2022	4
2024	2
2026	5

Applicants with the most clearances

Product code MWJ

Applicants holding the most 510(k) clearances under product code MWJ
Applicant	Clearances
Braemar Manufacturing, LLC	7
North East Monitoring, Inc.	5
Getemed Medizin- und Informationstechnik AG	4
Mortara Instrument, Inc.	3
Biotricity	2
Datrix LLC	2
Diagnostic Monitoring Software	2
Inovise Medical, Inc.	2
GE Healthcare	2
BTL Industries, Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order