The following data is part of a premarket notification filed by Hne Healthcare, Inc. with the FDA for Dopplex Surgical Probes.
| Device ID | K946300 |
| 510k Number | K946300 |
| Device Name: | DOPPLEX SURGICAL PROBES |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HNE HEALTHCARE, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko HNE HEALTHCARE, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-28 |
| Decision Date | 1995-07-26 |