The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Rme 325r.
| Device ID | K893674 |
| 510k Number | K893674 |
| Device Name: | RME 325R |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| 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 | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-07-20 |