The following data is part of a premarket notification filed by Dynamic Healthcare Technologies, Inc. with the FDA for Maxview Diagnostic Workstation.
Device ID | K984023 |
510k Number | K984023 |
Device Name: | MAXVIEW DIAGNOSTIC WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | DYNAMIC HEALTHCARE TECHNOLOGIES, INC. 615 CRESCENT EXECUTIVE CT. 5TH FLR. Lake Mary, FL 32746 -2109 |
Contact | Karen W White |
Correspondent | Karen W White DYNAMIC HEALTHCARE TECHNOLOGIES, INC. 615 CRESCENT EXECUTIVE CT. 5TH FLR. Lake Mary, FL 32746 -2109 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-12 |
Decision Date | 1998-12-08 |
Summary: | summary |