The following data is part of a premarket notification filed by Envitec-wismar Gmbh with the FDA for Envitec Medical Oxygen Senors, Models Oom101; 00m102/-1;oom103/-1/-1m;oom104;oom105;00m106.
| Device ID | K082655 |
| 510k Number | K082655 |
| Device Name: | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 |
| 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 | 2008-09-12 |
| Decision Date | 2008-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00619498279357 | K082655 | 000 |
| 04036616010962 | K082655 | 000 |
| 04036616000369 | K082655 | 000 |
| 04036616013505 | K082655 | 000 |
| 04036616010900 | K082655 | 000 |