Spectra Platinum
K-Number: K251932 · 2025-11-25
ApplicantUzinmedicare Co., Ltd.
Decision Date2025-11-25
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Spectra Platinum is a medical device manufactured by Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2025-11-25 under approval number K251932. 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 Platinum?
Spectra Platinum is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Uzinmedicare Co., Ltd.. The 510(k) number is K251932.
When was Spectra Platinum approved by the FDA?
Spectra Platinum received FDA 510(k) clearance on 2025-11-25, under approval number K251932.
What company makes Spectra Platinum?
Spectra Platinum is manufactured by Uzinmedicare Co., Ltd..
What is the FDA product code for Spectra Platinum?
The FDA product code for Spectra Platinum 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.