BEAR and BEAR mini
K-Number: K200803 · 2020-07-31
ApplicantForeo, Inc.
Decision Date2020-07-31
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BEAR and BEAR mini is a medical device manufactured by Foreo, Inc.. It received FDA 510(k) clearance on 2020-07-31 under approval number K200803. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BEAR and BEAR mini?
BEAR and BEAR mini is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Foreo, Inc.. The 510(k) number is K200803.
When was BEAR and BEAR mini approved by the FDA?
BEAR and BEAR mini received FDA 510(k) clearance on 2020-07-31, under approval number K200803.
What company makes BEAR and BEAR mini?
BEAR and BEAR mini is manufactured by Foreo, Inc..
What is the FDA product code for BEAR and BEAR mini?
The FDA product code for BEAR and BEAR mini is NFO.
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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.