The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Cp Flexible Coils/ Lp Circular Flex Coils.
Device ID | K935752 |
510k Number | K935752 |
Device Name: | CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Contact | Kathleen Rutherford |
Correspondent | Kathleen Rutherford SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-26 |
Decision Date | 1994-03-29 |