The following data is part of a premarket notification filed by Mipm Mammendorfer Institut Fur Physik Und Medizin with the FDA for Mri Patient Monitor Tesladuo.
| Device ID | K153739 |
| 510k Number | K153739 |
| Device Name: | MRI Patient Monitor TeslaDUO |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN OSKAR-VON-MILLER-STR. 6 Mammendorf, DE 82291 |
| Contact | Hans Schwaiger |
| Correspondent | Andre Kindsvater EMERGO GROUP 16 CONGRESS AVENUE SUITE 1400 Austin, TX 78701 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EMIP63000400 | K153739 | 000 |
| EMIP50101010 | K153739 | 000 |
| EMIP17000010 | K153739 | 000 |
| 04255629200553 | K153739 | 000 |
| 04255629200522 | K153739 | 000 |
| 04255629200515 | K153739 | 000 |
| 04255629200508 | K153739 | 000 |