The following data is part of a premarket notification filed by Envitec-wismar Gmbh with the FDA for Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped.
| Device ID | K992215 |
| 510k Number | K992215 |
| Device Name: | MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED |
| Classification | Oximeter |
| Applicant | ENVITEC-WISMAR GMBH N8259 COTTAGE DR. Fond Du Lac, WI 54937 |
| Contact | Stephen H Gorski |
| Correspondent | Stephen H Gorski ENVITEC-WISMAR GMBH N8259 COTTAGE DR. Fond Du Lac, WI 54937 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-01 |
| Decision Date | 2000-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04036616010207 | K992215 | 000 |
| 04036616009331 | K992215 | 000 |
| 04036616007528 | K992215 | 000 |
| 04036616007214 | K992215 | 000 |
| 04036616007146 | K992215 | 000 |
| 04036616005982 | K992215 | 000 |
| 04036616005494 | K992215 | 000 |
| 04036616000604 | K992215 | 000 |
| 04036616000581 | K992215 | 000 |