The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Noras Cpc Multifunctional Coil.
Device ID | K083578 |
510k Number | K083578 |
Device Name: | NORAS CPC MULTIFUNCTIONAL COIL |
Classification | Coil, Magnetic Resonance, Specialty |
Applicant | NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 Hoechberg, DE 97204 |
Contact | Zahed Sedighiani |
Correspondent | Zahed Sedighiani NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 Hoechberg, DE 97204 |
Product Code | MOS |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-03 |
Decision Date | 2009-01-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04251269201547 | K083578 | 000 |
04251269201530 | K083578 | 000 |
04251269201523 | K083578 | 000 |
04251269201516 | K083578 | 000 |
04251269201493 | K083578 | 000 |
04251269201486 | K083578 | 000 |
04251269200311 | K083578 | 000 |