The following data is part of a premarket notification filed by Siemens Medical Solution, Inc. Usa with the FDA for Cordless Coil.
Device ID | K050476 |
510k Number | K050476 |
Device Name: | CORDLESS COIL |
Classification | Coil, Magnetic Resonance, Specialty |
Applicant | SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 Malvern, PA 19355 |
Contact | Ana Ladino |
Correspondent | Ana Ladino SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 Malvern, PA 19355 |
Product Code | MOS |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-24 |
Decision Date | 2005-03-25 |
Summary: | summary |