The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Varicam.
Device ID | K953801 |
510k Number | K953801 |
Device Name: | VARICAM |
Classification | System, Tomography, Computed, Emission |
Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
Contact | Thomas J Spackman |
Correspondent | Thomas J Spackman ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-11 |
Decision Date | 1995-11-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VARICAM 76363906 2813701 Live/Registered |
PANASONIC CORPORATION 2002-01-25 |
VARICAM 73745736 1530682 Live/Registered |
POWER-FLAME, INC. 1988-08-12 |