The following data is part of a premarket notification filed by Ramsoft, Inc. with the FDA for Powerserver, Powerreader, Gateway And Powercache.
Device ID | K052460 |
510k Number | K052460 |
Device Name: | POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE |
Classification | System, Image Processing, Radiological |
Applicant | RAMSOFT, INC. 16 FOUR SEASONS PLACE SUITE 215 Toronto, CA M9b 6e5 |
Contact | Vijay Ramanathan |
Correspondent | Vijay Ramanathan RAMSOFT, INC. 16 FOUR SEASONS PLACE SUITE 215 Toronto, CA M9b 6e5 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-07 |
Decision Date | 2005-09-21 |
Summary: | summary |