# K083715: Beltbeat WF-400

- Pathway: 510(k) (Traditional)
- Applicant: Bonus Communicaciones Srl
- Decided: Sep 15, 2009 after 274 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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) Welch Allyn Micropaq Monitor (Model 406 /408) Software version 1.6X + Acuity Central Station: named in the summary without a submission number
- (no number) Philips Transmitters M2601B + IntelliVue Information Center (Philips Telemetry System): named in the summary without a submission number

## Indications for use
This monitoring system is intended to be used by clinicians for ECG signals monitoring of ambulatory and nonambulatory adult and pediatric patients in health care facilities. This product is intended to be used by trained health care professionals. It is not intended for home use.

Source page: https://510kreport.com/device/K083715
Methodology: https://510kreport.com/methodology