The following data is part of a premarket notification filed by Scientific Imaging, Inc. with the FDA for Virtual Medical Systems Model Vt3000.
Device ID | K052904 |
510k Number | K052904 |
Device Name: | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 |
Classification | Device, Nerve Conduction Velocity Measurement |
Applicant | SCIENTIFIC IMAGING, INC. 110 BASCOMB DRIVE Woodstock, GA 30189 |
Contact | Chris Johnson |
Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
Product Code | JXE |
CFR Regulation Number | 882.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-10-14 |
Decision Date | 2005-10-27 |