The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for High Resolution 10cm Diag. Ultra. Scanne.
| Device ID | K801060 |
| 510k Number | K801060 |
| Device Name: | HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-06 |
| Decision Date | 1980-06-04 |