The following data is part of a premarket notification filed by Siemens Medical Solutions with the FDA for Flex And Loop Coil Set 1.5 T.
| Device ID | K070629 |
| 510k Number | K070629 |
| Device Name: | FLEX AND LOOP COIL SET 1.5 T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SIEMENS MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE D91052 |
| Contact | Helmut Neumann |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-07 |
| Decision Date | 2007-03-26 |
| Summary: | summary |