FDA.report

510(k) K113317

Device
LIFECHOICE OXYGEN CONCENTRATOR
Applicant
INOVA LABS, INC.
510(k) number
K113317
Product code
CAW  
Decision
Substantially Equivalent (SESE)
Decision date
2011-12-28
Date received
2011-11-10
Regulation
868.5440
Classification name
Generator, Oxygen, Portable
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DAVID SHOCKLEY
Address
3500 Comsouth Dr. Suite 100 Austin TX US 78744 78744

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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