FDA 510(k)

OMF ASP System

K-Number: K220648 · 2022-08-11

Decision Date2022-08-11

Product CodeDZJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OMF ASP System is a medical device manufactured by Vha Dean. It received FDA 510(k) clearance on 2022-08-11 under approval number K220648. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMF ASP System?

OMF ASP System is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by Vha Dean. The 510(k) number is K220648.

When was OMF ASP System approved by the FDA?

OMF ASP System received FDA 510(k) clearance on 2022-08-11, under approval number K220648.

What company makes OMF ASP System?

OMF ASP System is manufactured by Vha Dean.

What is the FDA product code for OMF ASP System?

The FDA product code for OMF ASP System is DZJ.

Other Devices by Vha Dean

K222639VHA Radiotherapy Bolus

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.