The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Cardiofocal Collimator.
| Device ID | K914179 |
| 510k Number | K914179 |
| Device Name: | CARDIOFOCAL COLLIMATOR |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Contact | Irena Krutulis |
| Correspondent | Irena Krutulis SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-18 |
| Decision Date | 1991-10-30 |