The following data is part of a premarket notification filed by Ramsoft, Inc. with the FDA for Ultrapro Workstation.
Device ID | K942917 |
510k Number | K942917 |
Device Name: | ULTRAPRO WORKSTATION |
Classification | System, Digital Image Communications, Radiological |
Applicant | RAMSOFT, INC. 37 BANKVIEW CIRCLE Rexdale, Ontario, CA M9w 6s6 |
Contact | N Ramanathan |
Correspondent | N Ramanathan RAMSOFT, INC. 37 BANKVIEW CIRCLE Rexdale, Ontario, CA M9w 6s6 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-21 |
Decision Date | 1994-11-14 |