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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 the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) 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. The listed applicant is Suntech Medical, Inc.. The 510(k) number is K151520.

When did Oscar 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Oscar 2?

The FDA 510(k) record lists Suntech Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oscar 2?

The FDA product code for Oscar 2 is DXN.

Other records listing Suntech Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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