# Datex Medical Instrumentation, Inc.

- Location (FDA's records): Tewksbury, MA
- FDA decisions: 5 (1991–1997): 5 510(k) clearances
- Product codes: DXN (1), CBS (1), KOI (1), CCK (1), DQK (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- GE Healthcare: 2 (https://510kreport.com/company/ge-healthcare)
- Axon Systems, Inc.: 1 (https://510kreport.com/company/axon-systems)

## Its most-cited devices
- K955026: AS/3 NMT Module (1997), cited by 2
- K961063: AS/3 Cardiac Output & SVO2 Module (1996), cited by 1

## Recent decisions
- K955026: AS/3 NMT Module (Apr 28, 1997)
- K961063: AS/3 Cardiac Output & SVO2 Module (May 31, 1996)
- K960490: AS/3 Compact Airway Module M-Caiov (May 3, 1996)
- K953006: AS/3 Network Link (Sep 27, 1995)
- K912530: Cardiocap II (TM) (Sep 5, 1991)

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