Skypro, SP01 Mask
K-Number: K152197 · 2016-08-26
ApplicantSkypro Medical Supplies Company
Decision Date2016-08-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Skypro, SP01 Mask is a medical device manufactured by Skypro Medical Supplies Company. It received FDA 510(k) clearance on 2016-08-26 under approval number K152197. 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, SP01 Mask?
Skypro, SP01 Mask is a medical device that received FDA 510(k) clearance on 2016-08-26. It is manufactured by Skypro Medical Supplies Company. The 510(k) number is K152197.
When was Skypro, SP01 Mask approved by the FDA?
Skypro, SP01 Mask received FDA 510(k) clearance on 2016-08-26, under approval number K152197.
What company makes Skypro, SP01 Mask?
Skypro, SP01 Mask is manufactured by Skypro Medical Supplies Company.
What is the FDA product code for Skypro, SP01 Mask?
The FDA product code for Skypro, SP01 Mask 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.