The following data is part of a premarket notification filed by Lmt Medical Systems Gmbh with the FDA for Neonate Array Coils.
| Device ID | K091047 |
| 510k Number | K091047 |
| Device Name: | NEONATE ARRAY COILS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | LMT MEDICAL SYSTEMS GMBH OSTERWEIDE 8 Luebeck, DE 23562 |
| Contact | Kristina Luetje |
| Correspondent | Kristina Luetje LMT MEDICAL SYSTEMS GMBH OSTERWEIDE 8 Luebeck, DE 23562 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-13 |
| Decision Date | 2010-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260486610216 | K091047 | 000 |
| 04260486610599 | K091047 | 000 |
| 04260486610940 | K091047 | 000 |
| 04260486610957 | K091047 | 000 |
| 04260486610377 | K091047 | 000 |
| 04260486610612 | K091047 | 000 |
| 04260486610636 | K091047 | 000 |
| 04260486610230 | K091047 | 000 |
| 04260486610629 | K091047 | 000 |
| 04260486610155 | K091047 | 000 |
| 04260486610209 | K091047 | 000 |
| 04260486610582 | K091047 | 000 |