Spectra Wearable
K-Number: K220926 · 2022-12-12
ApplicantUzinmedicare Co., Ltd.
Decision Date2022-12-12
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Spectra Wearable is a medical device manufactured by Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2022-12-12 under approval number K220926. 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 Wearable?
Spectra Wearable is a medical device that received FDA 510(k) clearance on 2022-12-12. It is manufactured by Uzinmedicare Co., Ltd.. The 510(k) number is K220926.
When was Spectra Wearable approved by the FDA?
Spectra Wearable received FDA 510(k) clearance on 2022-12-12, under approval number K220926.
What company makes Spectra Wearable?
Spectra Wearable is manufactured by Uzinmedicare Co., Ltd..
What is the FDA product code for Spectra Wearable?
The FDA product code for Spectra Wearable 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.