The following data is part of a premarket notification filed by Envitec-wismar Gmbh with the FDA for Envitec Mysign O Oxygen Measuring Device.
| Device ID | K122290 |
| 510k Number | K122290 |
| Device Name: | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | ENVITEC-WISMAR GMBH S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen Gorski |
| Correspondent | Stephen Gorski ENVITEC-WISMAR GMBH S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2013-01-23 |
| Summary: | summary |