FDA.report

510(k) K132205

Device
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
Applicant
INOVA LABS, INC.
510(k) number
K132205
Product code
CAW  
Decision
Substantially Equivalent (SESE)
Decision date
2014-06-06
Date received
2013-07-16
Regulation
868.5440
Classification name
Generator, Oxygen, Portable
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
PAMELA M BUCKMAN
Address
2800 Pleasant Hill Rd., Suite 175 Suite 175 Pleasant Hill CA US 94523 94523

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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