# Spacelabs Healthcare Medical Equipment (Suzhou) CO

- Location (FDA's records): Nederland, CO
- FDA decisions: 1 (2009–2009): 1 510(k) clearance
- Product codes: MHX (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 4 (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 whose devices it cites most
- Zoe Medical, Inc.: 1 (https://510kreport.com/company/zoe-medical)
- Oridion Capnography, Inc.: 1 (https://510kreport.com/company/oridion-capnography)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)

## Firms that cite its devices most
- Zoe Medical, Inc.: 2 (https://510kreport.com/company/zoe-medical)
- Mortara Instrument, Inc.: 1 (https://510kreport.com/company/mortara-instrument)
- Spacelabs Medical, Inc.: 1 (https://510kreport.com/company/spacelabs-medical)

## Its most-cited devices
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software (2009), cited by 4

## Recent decisions
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software (Apr 30, 2009)

Source page: https://510kreport.com/company/spacelabs-healthcare-medical-equipment-suzhou