The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Stand Imaging Dose Calibrator Shielded Work Platform.
| Device ID | K940539 |
| 510k Number | K940539 |
| Device Name: | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM |
| Classification | Shield, Protective, Personnel |
| Applicant | STANDARD IMAGING, INC. 6213 MIDDLETON SPRINGS DRIVE, SUITE 205, P.O. BOX 352 Middleton, WI 53562 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle STANDARD IMAGING, INC. 6213 MIDDLETON SPRINGS DRIVE, SUITE 205, P.O. BOX 352 Middleton, WI 53562 |
| Product Code | KPY |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-03-16 |