The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Cathcor Desktop.
Device ID | K002137 |
510k Number | K002137 |
Device Name: | CATHCOR DESKTOP |
Classification | Computer, Diagnostic, Programmable |
Applicant | SIEMENS ELEMA AB ELECTROMEDICAL SYSTEMS GROUP 16 ELECTRONICS AVENUE Danvers, MA 01923 |
Contact | Dave Simard |
Correspondent | Dave Simard SIEMENS ELEMA AB ELECTROMEDICAL SYSTEMS GROUP 16 ELECTRONICS AVENUE Danvers, MA 01923 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-14 |
Decision Date | 2000-10-05 |