# K972848: Narkomed Mri Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Oct 30, 1997 after 90 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: 2 generations back to K930351 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K963994: Narkomed GS Anesthesia System, Draeger Medical, Inc. (1997) Summary page 1.
- K960861: Omicron Monitor, Delta Monitor, Core-M, Inc. (1996) Summary page 1.

## Most influential descendants
- K012446: Office Based Anesthesia Machine Mri, Model Oba-1 Mri (2001), 0 descendants of its own

## Indications for use
The NM-MRI is a continuous flow anesthesia system. The NM-MRI may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. The NM-MRI is indicated for use with the Driger Vapor® 19.1. The NM- MRI may be used in MRI scanner rooms with magnets up to 1.5 tesla, and with magnets over 1.5 tesla when installed using the NM-MRI High field Mounting Kit. Federal law restricts this device to sale by, or on the order of, a physician.

Source page: https://510kreport.com/device/K972848
Methodology: https://510kreport.com/methodology