Inovo, Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
6
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2099-2019Class IIInovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygApril 26, 2019
Z-0407-2018Class IIPURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000SOctober 9, 2017
Z-0760-2017Class IIINOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to July 21, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K141967PUREFILL OXYGEN COMPRESSORNovember 7, 2014
K113111CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTIONDecember 8, 2011
K103392CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVERDecember 17, 2010
K060751INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATORJuly 18, 2006
K051540INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATORSeptember 21, 2005
K031983INOVO, INC, ECONOMIZER CONSERVING REGULATORSeptember 15, 2003