# K963994: Narkomed GS Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Mar 19, 1997 after 166 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 K930351 (1993). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930351: Narkomed 2C Anesthesia System, Draeger Medical, Inc. (1993) Summary page 1.
- K953228: Narkomed AV2+ Anesthesia Ventilator, Draeger Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K972848: Narkomed Mri Anesthesia System (1997), 1 descendant of its own
- K012446: Office Based Anesthesia Machine Mri, Model Oba-1 Mri (2001), 0 descendants of its own
- K971425: Narkomed M Anesthesia System (M) (1997), 0 descendants of its own

## Indications for use
The NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume.

Source page: https://510kreport.com/device/K963994
Methodology: https://510kreport.com/methodology