The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Pfm-90 Ceiling Tube Support.
Device ID | K900234 |
510k Number | K900234 |
Device Name: | PFM-90 CEILING TUBE SUPPORT |
Classification | Tube Mount, X-ray, Diagnostic |
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 | IYB |
CFR Regulation Number | 892.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-17 |
Decision Date | 1990-02-26 |