The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Csp-a (ceiling Suspended Positioner-angio).
| Device ID | K924137 |
| 510k Number | K924137 |
| Device Name: | CSP-A (CEILING SUSPENDED POSITIONER-ANGIO) |
| Classification | System, X-ray, Angiographic |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | James W Morgan |
| Correspondent | James W Morgan FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-18 |
| Decision Date | 1992-12-28 |