The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Multi Dopplex, Md-1.
Device ID | K900882 |
510k Number | K900882 |
Device Name: | MULTI DOPPLEX, MD-1 |
Classification | Monitor, Ultrasonic, Nonfetal |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
Contact | James Britton |
Correspondent | James Britton HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
Product Code | JAF |
CFR Regulation Number | 892.1540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-26 |
Decision Date | 1990-08-22 |