Spectra S1Plus and Spectra S2 Plus
K-Number: K150476 · 2016-04-15
ApplicantUzinmedicare Co.
Decision Date2016-04-15
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Spectra S1Plus and Spectra S2 Plus is a medical device manufactured by Uzinmedicare Co.. It received FDA 510(k) clearance on 2016-04-15 under approval number K150476. 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 Spectra S1Plus and Spectra S2 Plus?
Spectra S1Plus and Spectra S2 Plus is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Uzinmedicare Co.. The 510(k) number is K150476.
When was Spectra S1Plus and Spectra S2 Plus approved by the FDA?
Spectra S1Plus and Spectra S2 Plus received FDA 510(k) clearance on 2016-04-15, under approval number K150476.
What company makes Spectra S1Plus and Spectra S2 Plus?
Spectra S1Plus and Spectra S2 Plus is manufactured by Uzinmedicare Co..
What is the FDA product code for Spectra S1Plus and Spectra S2 Plus?
The FDA product code for Spectra S1Plus and Spectra S2 Plus is HGX.
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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.