The following data is part of a premarket notification filed by Palodex Group Oy with the FDA for Cliniview.
Device ID | K162799 |
510k Number | K162799 |
Device Name: | Cliniview |
Classification | System, Image Processing, Radiological |
Applicant | Palodex Group Oy Nahkelantie 160 Tuusula, FI Fi-04300 |
Contact | Jouni Karkinen |
Correspondent | Jouni Karkinen Palodex Group Oy Nahkelantie 160 Tuusula, FI Fi-04300 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-05 |
Decision Date | 2017-04-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLINIVIEW 73712861 1504723 Dead/Cancelled |
CLINICOM, INCORPORATED 1988-02-22 |