# Datex-Engstrom, Inc.

- Location (FDA's records): Tewksbury, MA
- FDA decisions: 10 (1996–1998): 10 510(k) clearances
- Names in FDA's records: Datex-Engstrom, Inc. (9); Datex Engstrom AB (1)
- Product codes: DSI (2), CCK (1), MSX (1), CAH (1), DRT (1), KNT (1), DPS (1), MHX (1), BSZ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Datex-Ohmeda, Inc.: 5 (https://510kreport.com/company/datex-ohmeda)
- GE Healthcare Finland Oy: 1 (https://510kreport.com/company/ge-healthcare-finland)
- A-M Systems, Inc.: 1 (https://510kreport.com/company/a-m-systems)
- Draeger Medical, Inc.: 1 (https://510kreport.com/company/draeger-medical)

## Its most-cited devices
- K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu) (1998), cited by 6
- K964204: Engstrom Hmef 1000 (1996), cited by 2

## Recent decisions
- K983366: Trip Tonometry Catheter, 16F (Dec 23, 1998)
- K982091: CS/3 Compact Airway Module, M-Covx (Dec 22, 1998)
- K981378: Datex-Engstrom Light Monitor Models F-LM1, F-LMP1 (Nov 3, 1998)
- K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu) (Oct 30, 1998)
- K980362: Mri Compatible Monitor and Accessories (Jun 30, 1998)
- K974792: CS/3(TM) Monitors* (Jun 2, 1998)
- K980384: Trip Tonometry Catheter, 18F (May 1, 1998)
- K974747: CS/3 Arrhythmia Workstation (Apr 23, 1998)

Source page: https://510kreport.com/company/datex-engstrom