The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Carbon Fiber Pallet.
| Device ID | K934766 |
| 510k Number | K934766 |
| Device Name: | CARBON FIBER PALLET |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Contact | Irena M Krutulis |
| Correspondent | Irena M Krutulis SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-04 |
| Decision Date | 1994-02-18 |