The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Op3/vp4.
| Device ID | K924516 |
| 510k Number | K924516 |
| Device Name: | OP3/VP4 |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Contact | Andy Wood |
| Correspondent | Andy Wood HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-04 |
| Decision Date | 1993-06-28 |