# K905575: Modified Models 2000W and 2000W Option H Apnea Mon

- Pathway: 510(k) (Traditional)
- Applicant: Edentec Corp.
- Decided: Jun 20, 1991 after 190 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962781: Corometrics Model 510 and 511 Monitor (1997), 0 descendants of its own
- K963400: Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and N-3200 Display/Printer (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K905575
Methodology: https://510kreport.com/methodology