# K030611: Modification to Suzanne Portable Polysomnograph System

- Pathway: 510(k) (Special)
- Applicant: Nellcor Puritan Bennett (Melville), Ltd.
- Decided: Mar 24, 2003 after 26 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: 6 generations back to K962603 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990565: Suzanne, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002)

## Indications for use
The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders. A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.

Source page: https://510kreport.com/device/K030611
Methodology: https://510kreport.com/methodology