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FDA 510(k)

Synergy Gold (SG) Portable (Models MM011450 and MM011460)

K-Number: K210124 · 2021-10-19

ApplicantUzinmedicare Co.
Decision Date2021-10-19
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a medical device manufactured by Uzinmedicare Co.. It received FDA 510(k) clearance on 2021-10-19 under approval number K210124. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synergy Gold (SG) Portable (Models MM011450 and MM011460)?

Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Uzinmedicare Co.. The 510(k) number is K210124.

When was Synergy Gold (SG) Portable (Models MM011450 and MM011460) approved by the FDA?

Synergy Gold (SG) Portable (Models MM011450 and MM011460) received FDA 510(k) clearance on 2021-10-19, under approval number K210124.

What company makes Synergy Gold (SG) Portable (Models MM011450 and MM011460)?

Synergy Gold (SG) Portable (Models MM011450 and MM011460) is manufactured by Uzinmedicare Co..

What is the FDA product code for Synergy Gold (SG) Portable (Models MM011450 and MM011460)?

The FDA product code for Synergy Gold (SG) Portable (Models MM011450 and MM011460) is HGX.

Related Clinical Trials

NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING

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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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