# Shenzhen Envisen Industry Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 2 (2011–2022): 2 510(k) clearances
- Names in FDA's records: Shenzhen Envisen Industry Co., Ltd. (1); Shenzhen Envisen Industry Co. Limited (1)
- Product codes: FLL (1), DQA (1)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 0 (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 whose devices it cites most
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Nonin Medical, Inc.: 2 (https://510kreport.com/company/nonin-medical)
- Deroyal Industries, Inc.: 1 (https://510kreport.com/company/deroyal-industries)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)
- Smiths Medical Pm, Inc.: 1 (https://510kreport.com/company/smiths-medical-pm)
- Criticare Systems, Inc.: 1 (https://510kreport.com/company/criticare-systems)
- Ohmeda Medical: 1 (https://510kreport.com/company/ohmeda-medical)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)

## Recent decisions
- K212945: Sterile Disposable Temperature Probe (Mar 1, 2022)
- K103584: Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda  Compatible Disposable and Reusable SPO2 Sensors (Jun 10, 2011)

Source page: https://510kreport.com/company/shenzhen-envisen-industry