The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for 13c/1h Occipital Headcoil For Magnetom Allegra.
Device ID | K042718 |
510k Number | K042718 |
Device Name: | 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA |
Classification | Coil, Magnetic Resonance, Specialty |
Applicant | SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY E-50 Malvern, PA 19355 |
Contact | Nealie Hartman |
Correspondent | Nealie Hartman SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY E-50 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 | 2004-09-30 |
Decision Date | 2004-11-12 |
Summary: | summary |