The following data is part of a premarket notification filed by Leiker Regulatory & Quality Consulting with the FDA for Chison Digital Ultrasound System, Convex Probe, Linear Probe, Transvaginal Micro-convex Probe, Transrectal Linear Probe.
| Device ID | K112539 |
| 510k Number | K112539 |
| Device Name: | CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | LEIKER REGULATORY & QUALITY CONSULTING 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker LEIKER REGULATORY & QUALITY CONSULTING 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-01-30 |
| Summary: | summary |