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 |