The following data is part of a premarket notification filed by Mipm Mammendorfer Institut Fur Physik Und Medizin with the FDA for Mri Patient Monitoring System Tesla M3.
| Device ID | K142032 |
| 510k Number | K142032 |
| Device Name: | MRI PATIENT MONITORING SYSTEM TESLA M3 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN PRINSESSEGRACHT 20 The Hague, NL 2514ap |
| Contact | Andre Kindsvater |
| Correspondent | Andre Kindsvater MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN PRINSESSEGRACHT 20 The Hague, NL 2514ap |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-25 |
| Decision Date | 2015-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04255629200355 | K142032 | 000 |
| 04255629200669 | K142032 | 000 |
| 04255629200676 | K142032 | 000 |
| 04255629200683 | K142032 | 000 |
| 04255629200690 | K142032 | 000 |
| 04255629200706 | K142032 | 000 |
| 04255629200720 | K142032 | 000 |
| 04255629200737 | K142032 | 000 |
| 04255629200744 | K142032 | 000 |
| EMIP50100490 | K142032 | 000 |
| EMIP50101030 | K142032 | 000 |
| EMIP18000010 | K142032 | 000 |
| EMIP50100120 | K142032 | 000 |
| EMIP50100130 | K142032 | 000 |
| 04255629200652 | K142032 | 000 |
| 04255629200645 | K142032 | 000 |
| 04255629200379 | K142032 | 000 |
| 04255629200874 | K142032 | 000 |
| 04255629200881 | K142032 | 000 |
| 04255629200898 | K142032 | 000 |
| 04255629200911 | K142032 | 000 |
| 04255629200928 | K142032 | 000 |
| 04255629200935 | K142032 | 000 |
| 04255629200485 | K142032 | 000 |
| 04255629200492 | K142032 | 000 |
| 04255629200539 | K142032 | 000 |
| 04255629200546 | K142032 | 000 |
| 04255629200621 | K142032 | 000 |
| 04255629200638 | K142032 | 000 |
| EMIP50100140 | K142032 | 000 |
| EMIP50100150 | K142032 | 000 |
| EMIP50100220 | K142032 | 000 |
| EMIP52000670 | K142032 | 000 |
| EMIP52000680 | K142032 | 000 |
| EMIP52000690 | K142032 | 000 |
| EMIP53000280 | K142032 | 000 |
| EMIP54000171 | K142032 | 000 |
| EMIP54000401 | K142032 | 000 |
| EMIP54000411 | K142032 | 000 |
| EMIP54000421 | K142032 | 000 |
| EMIP54000431 | K142032 | 000 |
| EMIP54000441 | K142032 | 000 |
| EMIP54500120 | K142032 | 000 |
| EMIP54500150 | K142032 | 000 |
| EMIP62100310 | K142032 | 000 |
| EMIP52000660 | K142032 | 000 |
| EMIP52000640 | K142032 | 000 |
| EMIP50100230 | K142032 | 000 |
| EMIP50100240 | K142032 | 000 |
| EMIP50101000 | K142032 | 000 |
| EMIP51000380 | K142032 | 000 |
| EMIP51000390 | K142032 | 000 |
| EMIP51000400 | K142032 | 000 |
| EMIP51000410 | K142032 | 000 |
| EMIP51000420 | K142032 | 000 |
| EMIP51000430 | K142032 | 000 |
| EMIP51000440 | K142032 | 000 |
| EMIP52000590 | K142032 | 000 |
| EMIP52000620 | K142032 | 000 |
| EMIP52000630 | K142032 | 000 |
| EMIP62100320 | K142032 | 000 |