The following data is part of a premarket notification filed by Medstone Intl., Inc. with the FDA for Sts(tm) Fluoroscopic Imaging Module.
| Device ID | K905278 |
| 510k Number | K905278 |
| Device Name: | STS(TM) FLUOROSCOPIC IMAGING MODULE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | MEDSTONE INTL., INC. 9975 TOLEDO Irvine, CA 92718 |
| Contact | Enid Rokaw |
| Correspondent | Enid Rokaw MEDSTONE INTL., INC. 9975 TOLEDO Irvine, CA 92718 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-23 |
| Decision Date | 1991-02-04 |