The following data is part of a premarket notification filed by Quantel Medical S.a. with the FDA for Compact Touch Sts.
| Device ID | K102198 |
| 510k Number | K102198 |
| Device Name: | COMPACT TOUCH STS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | QUANTEL MEDICAL S.A. 601 HAGGERTY LANE Bozeman, MT 59715 |
| Contact | Mike Johnson M.d. |
| Correspondent | Mike Johnson M.d. QUANTEL MEDICAL S.A. 601 HAGGERTY LANE Bozeman, MT 59715 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-04 |
| Decision Date | 2010-11-05 |
| Summary: | summary |