The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Polydoros Sx 65 And 80.
| Device ID | K950883 |
| 510k Number | K950883 |
| Device Name: | POLYDOROS SX 65 AND 80 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-28 |
| Decision Date | 1995-04-03 |