The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Rheo Dopplex Ii (rd 2).
Device ID | K964699 |
510k Number | K964699 |
Device Name: | RHEO DOPPLEX II (RD 2) |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 RTE. 33 EAST Manalapan, NJ 07726 |
Contact | Audrey Witko |
Correspondent | Audrey Witko HUNTLEIGH TECHNOLOGY, INC. 227 RTE. 33 EAST Manalapan, NJ 07726 |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-25 |
Decision Date | 1997-02-21 |