The following data is part of a premarket notification filed by Lmt Medical Systems Gmbh with the FDA for Nhac 16.
| Device ID | K171515 |
| 510k Number | K171515 |
| Device Name: | NHAC 16 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | LMT Medical Systems GmbH Maria-Goeppert-Str. 5 Lubeck, DE 23562 |
| Contact | Thomas Plein |
| Correspondent | Thomas Plein LMT Medical Systems GmbH Maria-Goeppert-Str. 5 Lubeck, DE 23562 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-24 |
| Decision Date | 2017-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260486610445 | K171515 | 000 |
| 04260486610438 | K171515 | 000 |
| 04260486610513 | K171515 | 000 |
| 04260486610469 | K171515 | 000 |
| 04260486610544 | K171515 | 000 |
| 04260486610537 | K171515 | 000 |
| 04260486610483 | K171515 | 000 |