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 |