The following data is part of a premarket notification filed by Envitec-wismar Gmbh with the FDA for Envitec Reusable Multi-site Y Spo2 Sensors.
| Device ID | K043463 |
| 510k Number | K043463 |
| Device Name: | ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS |
| Classification | Oximeter |
| Applicant | ENVITEC-WISMAR GMBH S65 W35739 PIPER RD Eagle, WI 53119 |
| Contact | Stephen Gorski |
| Correspondent | Stephen Gorski ENVITEC-WISMAR GMBH S65 W35739 PIPER RD Eagle, WI 53119 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-15 |
| Decision Date | 2005-02-11 |
| Summary: | summary |