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 |