# K964494: Sleepwizard

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Feb 4, 1997 after 88 days
- Product code: MNR (Ventilatory Effort Recorder)
- 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
Longest line of descent: 1 generation back to K934599 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934599: Sandman, Melville Software, Ltd. (1994) Summary page 1.
- K943673: MMC Amplifier, Melville Software, Ltd. (1994) Summary page 1.

## Indications for use
The SleepWizard is intended for use in collecting, recording and displaying physiological data to be used in diagnosing sleep disorders such as obstructive sleep apnea in patients weighing over 20 kg in a clinical or home environment.

Source page: https://510kreport.com/device/K964494
Methodology: https://510kreport.com/methodology