# K102723: Model 950-12L Holter Recorder Without Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Memtec Corp.
- Decided: Dec 9, 2010 after 79 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871344 (1987). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022540: Cardio ID+(RZ153+), Rozinn Electronics, Inc. (2002) Summary page 1.
- K001288: DR180-II, North East Monitoring, Inc. (2000) Summary page 1.
- K032466: Spiderview, Ela Medical, Inc. (2003) Summary page 1.
- K993617: Digitrakplus Holter Recorder, Braemar Corp. (1999) Summary page 1.

## Most influential descendants
- K103706: The Core (Cardiac Outpatient Realtime Ecg) Monitor (2011), 1 descendant of its own
- K181658: MobileECG 2 BT (2019), 0 descendants of its own
- K142352: CardiacLinx (2015), 0 descendants of its own

## Indications for use
The Model 950-12L Halter recorder is intended to record continuous data for up to 120 hours for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as: *Palpitations, shortness of breath, chest pain, syncope *Evaluating pacemakers *Heart rate variability's *Evaluating medications *Clinical studies This is a prescriptive device and is to be used by trained physicians and other licensed medical professionals only. The Memtec Model 950-12L recorder does not perform diagnostics. The data provided shall be used by physicians for diagnostic evaluations. The Memtec Model 950-12L recorder is not intended for infants weighing less than 22 Lbs. (10 Kg).

Source page: https://510kreport.com/device/K102723
Methodology: https://510kreport.com/methodology