LAITEST Medical Face Mask
K-Number: K214035 · 2022-09-13
ApplicantR&R Medical Corporation, Ltd.
Decision Date2022-09-13
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LAITEST Medical Face Mask is a medical device manufactured by R&R Medical Corporation, Ltd.. It received FDA 510(k) clearance on 2022-09-13 under approval number K214035. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LAITEST Medical Face Mask?
LAITEST Medical Face Mask is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by R&R Medical Corporation, Ltd.. The 510(k) number is K214035.
When was LAITEST Medical Face Mask approved by the FDA?
LAITEST Medical Face Mask received FDA 510(k) clearance on 2022-09-13, under approval number K214035.
What company makes LAITEST Medical Face Mask?
LAITEST Medical Face Mask is manufactured by R&R Medical Corporation, Ltd..
What is the FDA product code for LAITEST Medical Face Mask?
The FDA product code for LAITEST Medical Face Mask is FXX.
Other Devices by R&R Medical Corporation, Ltd.
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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.