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 |