# K230148: Vlab

- Pathway: 510(k) (Traditional)
- Applicant: Dormotech Medical, Ltd.
- Decided: Oct 11, 2023 after 265 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- 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 K090484 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090484: Alice PDX, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 5.

## Indications for use
The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.

Source page: https://510kreport.com/device/K230148
Methodology: https://510kreport.com/methodology