# K083382: Chroma, Model: RZ153C

- Pathway: 510(k) (Traditional)
- Applicant: Scottcare Corporation
- Decided: Aug 13, 2009 after 272 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: 2 generations back to K950944 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993618: DXP1000 Holter Recorder, Braemar Corp. (1999) Summary page 1.

## Indications for use
The intended use of the Chroma Holter Recorder RZ153C is to perform ambulatory ECG on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording.

Source page: https://510kreport.com/device/K083382
Methodology: https://510kreport.com/methodology