The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Modification Of: Rheo Dopplex Ii.
| Device ID | K984307 |
| 510k Number | K984307 |
| Device Name: | MODIFICATION OF: RHEO DOPPLEX II |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 227 RT. 33 EAST Manalapan, NJ 07726 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko HUNTLEIGH HEALTHCARE, INC. 227 RT. 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 | 1998-12-02 |
| Decision Date | 1999-01-12 |
| Summary: | summary |