The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Noras Or Head Holder.
Device ID | K071179 |
510k Number | K071179 |
Device Name: | NORAS OR HEAD HOLDER |
Classification | Coil, Magnetic Resonance, Specialty |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Contact | Judith Campbell |
Correspondent | Judith Campbell SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Product Code | MOS |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-27 |
Decision Date | 2007-06-13 |
Summary: | summary |