The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Transvaginal Probe, Model Ed65m-tv.
| Device ID | K861371 |
| 510k Number | K861371 |
| Device Name: | TRANSVAGINAL PROBE, MODEL ED65M-TV |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | ELSCINT, INC. 751 EXPRESSWAY DR. Itasca, IL 60143 |
| Contact | Robert E Kenney |
| Correspondent | Robert E Kenney ELSCINT, INC. 751 EXPRESSWAY DR. Itasca, IL 60143 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-11 |
| Decision Date | 1986-07-14 |