# Datex Division Instrumentarium Corp.

- Location (FDA's records): Helsinki, Finland, FI
- FDA decisions: 55 (1982–1997): 55 510(k) clearances
- Product codes: CCK (9), DQA (8), CBQ (7), DPS (4), BSZ (4), DSK (3), DXN (3), CBS (3), DRI (2), BZL (2), DSF (1), IKN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 14 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Invivo Research, Inc.: 4 (https://510kreport.com/company/invivo-research)
- Datex-Ohmeda, Inc.: 4 (https://510kreport.com/company/datex-ohmeda)
- GE Healthcare: 3 (https://510kreport.com/company/ge-healthcare)
- Draeger Medical, Inc.: 1 (https://510kreport.com/company/draeger-medical)
- Epic Medical Equipment Services, Inc.: 1 (https://510kreport.com/company/epic-medical-equipment-services)
- Hewlett-Packard Co.: 1 (https://510kreport.com/company/hewlett-packard)

## Its most-cited devices
- K935477: AS/3(TM) Anesthesia Monitor Syst Interface Board (1994), cited by 2
- K932098: Capnomac  Ultima Anesthesia Monitor (1993), cited by 2
- K922876: AS/3 Cop Module (1993), cited by 1
- K933156: Datex as/3 Patient Monitor (1994), cited by 1
- K903104: Capnomac Ultima (TM) Anesthesia Monitor (1991), cited by 1
- K905140: Satlite Plus Pulse Oximeter (1991), cited by 1

## Recent decisions
- K953175: AS/3 Estpr Module (Feb 6, 1997)
- K961247: AS/3 Light Monitor (Oct 23, 1996)
- K943458: AS/3 Airway Module (Feb 14, 1995)
- K945234: AS/3 Memory Module, M0MEM (Jan 27, 1995)
- K933156: Datex as/3 Patient Monitor (Dec 30, 1994)
- K933285: Datex as/3 TM Anaesthesia Monitor (Nov 14, 1994)
- K943456: AS/3 Nellcor Compatible Saturation Moodule, M-Nsat (Oct 17, 1994)
- K923172: Anaesthesia Record Keeper (Aug 9, 1994)

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