The following data is part of a premarket notification filed by Ron-tech Medical Ltd. with the FDA for Transvaginal Ultrasound Probe Holder System.
| Device ID | K032585 |
| 510k Number | K032585 |
| Device Name: | TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM |
| Classification | Tenaculum, Uterine |
| Applicant | RON-TECH MEDICAL LTD. 26 HASIVIM ST. KIRYAT MATALON Petach-tikva, IL 49170 |
| Contact | Doron Kilchevsky |
| Correspondent | Doron Kilchevsky RON-TECH MEDICAL LTD. 26 HASIVIM ST. KIRYAT MATALON Petach-tikva, IL 49170 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-21 |
| Decision Date | 2004-01-09 |
| Summary: | summary |