The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Polytron T.o.p. (time, Operation, Performance).
| Device ID | K933664 |
| 510k Number | K933664 |
| Device Name: | POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) |
| Classification | System, X-ray, Angiographic |
| 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 | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-28 |
| Decision Date | 1993-12-15 |