The following data is part of a premarket notification filed by Envitec-wismar Gmbh with the FDA for Mysign S Pulse Oximeter, Mysign Pc Software (optional), Softtip Large R-3211-31, Finger Clip F-3211-31.
| Device ID | K133064 |
| 510k Number | K133064 |
| Device Name: | MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04036616010054 | K133064 | 000 |
| 04036616009874 | K133064 | 000 |