The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Nomos Corvus 5.0m.
Device ID | K032209 |
510k Number | K032209 |
Device Name: | NOMOS CORVUS 5.0M |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | NOMOS CORP. 200 WEST KENSINGER DR. SUITE 100 Cranberry Township, PA 16066 |
Contact | Francis X Dobscha |
Correspondent | Francis X Dobscha NOMOS CORP. 200 WEST KENSINGER DR. SUITE 100 Cranberry Township, PA 16066 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-18 |
Decision Date | 2003-08-21 |
Summary: | summary |