The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Rms 180.
Device ID | K893673 |
510k Number | K893673 |
Device Name: | RMS 180 |
Classification | Table, Radiographic, Tilting |
Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
Contact | Richard Lucas |
Correspondent | Richard Lucas FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-15 |
Decision Date | 1989-07-20 |