# K121860: ESA615

- Pathway: 510(k) (Traditional)
- Applicant: Fluke Biomedical
- Decided: Jan 25, 2013 after 213 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MPS450: named in the summary without a submission number

## Indications for use
The ESA615 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA615 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA615 provides following function categories: * ECG Functions * ECG-Performance Testing

Source page: https://510kreport.com/device/K121860
Methodology: https://510kreport.com/methodology