# Envitec-Wismar GmbH

- Location (FDA's records): Egale, WI
- FDA decisions: 9 (2000–2014): 9 510(k) clearances
- Product codes: DQA (7), CCL (2)
- Predicates its devices cite: 21 (4 its own); citations of its devices by later devices: 11 (4 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
- Philips Medical Systems, Inc.: 3 (https://510kreport.com/company/philips-medical-systems)
- Maxtec, LLC: 2 (https://510kreport.com/company/maxtec)
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Nellcor, Inc.: 1 (https://510kreport.com/company/nellcor)
- Ohmeda Medical: 1 (https://510kreport.com/company/ohmeda-medical)
- Biochem International, Inc.: 1 (https://510kreport.com/company/biochem-international)
- Criticare Systems, Inc.: 1 (https://510kreport.com/company/criticare-systems)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)

## Firms that cite its devices most
- Elekon Industries U.S.A., Inc.: 3 (https://510kreport.com/company/elekon-industries-usa)
- Athena Gtx: 1 (https://510kreport.com/company/athena-gtx)
- Digicare Biomedical Technology, Inc.: 1 (https://510kreport.com/company/digicare-biomedical-technology)
- Sentec AG: 1 (https://510kreport.com/company/sentec)
- Nonin Medical, Inc.: 1 (https://510kreport.com/company/nonin-medical)

## Its most-cited devices
- K992215: Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped (2000), cited by 4
- K122290: Envitec Mysign O Oxygen Measuring Device (2013), cited by 2
- K070193: Envitec Oxipen Pulse Oximeter and Accessories (2007), cited by 2
- K060675: Envitec Reusable Softip Y SPO2 Sensors (2006), cited by 1
- K043463: Envitec Reusable Multi-Site Y SPO2 Sensors (2005), cited by 1
- K082655: Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 (2008), cited by 1

## Recent decisions
- K133064: Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31 (May 2, 2014)
- K122290: Envitec Mysign O Oxygen Measuring Device (Jan 23, 2013)
- K102270: Envitec Reusable SPO2 Sensors Type Nihon-Kohden (Feb 22, 2011)
- K090438: Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15, Reusable Envitec Ear SPO2 Sensor (Jul 24, 2009)
- K082655: Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 (Nov 25, 2008)
- K070193: Envitec Oxipen Pulse Oximeter and Accessories (May 2, 2007)
- K060675: Envitec Reusable Softip Y SPO2 Sensors (Jul 17, 2006)
- K043463: Envitec Reusable Multi-Site Y SPO2 Sensors (Feb 11, 2005)

Source page: https://510kreport.com/company/envitec-wismar