Skypro, SP02 Mask (3)
K-Number: K202255 · 2021-12-24
ApplicantSkypro Medical Supplies Company
Decision Date2021-12-24
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Skypro, SP02 Mask (3) is a medical device manufactured by Skypro Medical Supplies Company. It received FDA 510(k) clearance on 2021-12-24 under approval number K202255. 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 Skypro, SP02 Mask (3)?
Skypro, SP02 Mask (3) is a medical device that received FDA 510(k) clearance on 2021-12-24. It is manufactured by Skypro Medical Supplies Company. The 510(k) number is K202255.
When was Skypro, SP02 Mask (3) approved by the FDA?
Skypro, SP02 Mask (3) received FDA 510(k) clearance on 2021-12-24, under approval number K202255.
What company makes Skypro, SP02 Mask (3)?
Skypro, SP02 Mask (3) is manufactured by Skypro Medical Supplies Company.
What is the FDA product code for Skypro, SP02 Mask (3)?
The FDA product code for Skypro, SP02 Mask (3) is FXX.
Other Devices by Skypro Medical Supplies Company
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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.