Decision Date2020-12-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Fever Garde is the device name listed in this FDA 510(k) record. The listed applicant is Hubdic Co., Ltd.. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K191978. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fever Garde?
Fever Garde is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Hubdic Co., Ltd.. The 510(k) number is K191978.
When did Fever Garde receive FDA 510(k) clearance?
Fever Garde received FDA 510(k) clearance on 2020-12-18, under 510(k) number K191978.
Who is the listed applicant for Fever Garde?
The FDA 510(k) record lists Hubdic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fever Garde?
The FDA product code for Fever Garde is FLL.
Related Devices (Code: FLL)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.