The following data is part of a premarket notification filed by Mrc Systems Gmbh with the FDA for Konrad, Model V.2.0.
Device ID | K022307 |
510k Number | K022307 |
Device Name: | KONRAD, MODEL V.2.0 |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | MRC SYSTEMS GMBH HANS-BUNTE-STR. 10 Heidelberg, DE 69123 |
Contact | Mark-aleksi Keller-reichenbecher |
Correspondent | Mark-aleksi Keller-reichenbecher MRC SYSTEMS GMBH HANS-BUNTE-STR. 10 Heidelberg, DE 69123 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-16 |
Decision Date | 2002-10-08 |
Summary: | summary |