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FDA 510(k)

Oscar 2

K-Number: K151520 · 2016-02-19

ApplicantSuntech Medical, Inc.
Decision Date2016-02-19
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oscar 2 is a medical device manufactured by Suntech Medical, Inc.. It received FDA 510(k) clearance on 2016-02-19 under approval number K151520. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oscar 2?

Oscar 2 is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Suntech Medical, Inc.. The 510(k) number is K151520.

When was Oscar 2 approved by the FDA?

Oscar 2 received FDA 510(k) clearance on 2016-02-19, under approval number K151520.

What company makes Oscar 2?

Oscar 2 is manufactured by Suntech Medical, Inc..

What is the FDA product code for Oscar 2?

The FDA product code for Oscar 2 is DXN.

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Official Source

View on FDA Database →

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

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