# K963711: Baby Dopplex (3000)

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: Sep 12, 1997 after 361 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921957 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921957: Hewlett-Packard Model M1351A Fetal Monitor, Hewlett-Packard Co. (1993) Summary page 1.

## Most influential descendants
- K990569: Baby Dopplex 4000, Model BD 4000 (2000), 0 descendants of its own

## Indications for use
The Baby Dopplex® 3000 is intended for use as a fetal monitor to perform cardiotocographs (“CTG”), i.e., fetal monitoring. The Baby Dopplex® 3000 is indicated for use in all areas of fetal monitoring except where internal scalp clip monitoring and/or intrauterine pressure measurement is required.

Source page: https://510kreport.com/device/K963711
Methodology: https://510kreport.com/methodology