The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Ect Carbon Fiber Pallet, Modification.
| Device ID | K912481 |
| 510k Number | K912481 |
| Device Name: | ECT CARBON FIBER PALLET, MODIFICATION |
| Classification | Bed, Scanning, Nuclear |
| 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 | IYZ |
| CFR Regulation Number | 892.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-23 |
| Decision Date | 1991-08-02 |