# K973949: Perioperative Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Feb 6, 1998 after 113 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- 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 K900937 (1990). 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)
- K900937: O.R. Data Manager, Draeger Medical, Inc. (1990) Summary page 1.

## Indications for use
The Perioperative Data Management System is indicated for electronically collecting, displaying, and recording perioperative information. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K973949
Methodology: https://510kreport.com/methodology