The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Elite 5000.
Device ID | K905501 |
510k Number | K905501 |
Device Name: | ELITE 5000 |
Classification | Table, Radiographic, Tilting |
Applicant | FISCHER IMAGING CORP. 2301 WINDSOR CT. Addison, IL 60101 |
Contact | William J Engel |
Correspondent | William J Engel FISCHER IMAGING CORP. 2301 WINDSOR CT. Addison, IL 60101 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-07 |
Decision Date | 1991-01-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ELITE 5000 77572137 not registered Dead/Abandoned |
Shaul Ben Avraham 2008-09-17 |