The following data is part of a premarket notification filed by Ipgdx, Llc with the FDA for Bia / Vitality Analyzer.
Device ID | K130856 |
510k Number | K130856 |
Device Name: | BIA / VITALITY ANALYZER |
Classification | Analyzer, Body Composition |
Applicant | IPGDX, LLC 33 Golden Eagle Lane Littleton, CO 80127 |
Contact | Kevin Walls |
Correspondent | Kevin Walls IPGDX, LLC 33 Golden Eagle Lane Littleton, CO 80127 |
Product Code | MNW |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-28 |
Decision Date | 2013-11-25 |