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 |