The following data is part of a premarket notification filed by Nuvon, Inc. with the FDA for Vector Event Grid Architecture (vega) System.
Device ID | K102135 |
510k Number | K102135 |
Device Name: | VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM |
Classification | Medical Computers And Software |
Applicant | NUVON, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan NUVON, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
Product Code | LNX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-29 |
Decision Date | 2010-10-22 |
Summary: | summary |