The following data is part of a premarket notification filed by Nomos Corp. with the FDA for The Nomos Minicrane.
Device ID | K964740 |
510k Number | K964740 |
Device Name: | THE NOMOS MINICRANE |
Classification | Couch, Radiation Therapy, Powered |
Applicant | NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
Contact | Marvin L Sussman, Ph.d. |
Correspondent | Marvin L Sussman, Ph.d. NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
Product Code | JAI |
CFR Regulation Number | 892.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-26 |
Decision Date | 1997-02-11 |
Summary: | summary |