The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Stretcher Table.
Device ID | K884292 |
510k Number | K884292 |
Device Name: | STRETCHER TABLE |
Classification | Cradle, Patient, Radiologic |
Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
Contact | Richard S Lucas |
Correspondent | Richard S Lucas FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
Product Code | KXH |
CFR Regulation Number | 892.1830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-12 |
Decision Date | 1989-03-31 |