The following data is part of a premarket notification filed by Ron-tech Medical Ltd. with the FDA for Transvaginal Ultrasound Probe Holder Device.
| Device ID | K992071 |
| 510k Number | K992071 |
| Device Name: | TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE |
| Classification | Tenaculum, Uterine |
| Applicant | RON-TECH MEDICAL LTD. P.O. BOX 454 Ginot Shomron, IL 44853 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein RON-TECH MEDICAL LTD. P.O. BOX 454 Ginot Shomron, IL 44853 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-18 |
| Decision Date | 1999-08-27 |