Spectra S3 Plus
K-Number: K181784 · 2018-11-30
ApplicantUzinmedicare Co.
Decision Date2018-11-30
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Spectra S3 Plus is a medical device manufactured by Uzinmedicare Co.. It received FDA 510(k) clearance on 2018-11-30 under approval number K181784. 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 S3 Plus?
Spectra S3 Plus is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Uzinmedicare Co.. The 510(k) number is K181784.
When was Spectra S3 Plus approved by the FDA?
Spectra S3 Plus received FDA 510(k) clearance on 2018-11-30, under approval number K181784.
What company makes Spectra S3 Plus?
Spectra S3 Plus is manufactured by Uzinmedicare Co..
What is the FDA product code for Spectra S3 Plus?
The FDA product code for Spectra S3 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.