Decision Date2020-04-14
Product CodeMLY
DecisionSubstantially Equivalent
Device Summary
Vapocoolshot Mist is a medical device manufactured by Vapocoolshot, Inc.. It received FDA 510(k) clearance on 2020-04-14 under approval number K193349. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vapocoolshot Mist?
Vapocoolshot Mist is a medical device that received FDA 510(k) clearance on 2020-04-14. It is manufactured by Vapocoolshot, Inc.. The 510(k) number is K193349.
When was Vapocoolshot Mist approved by the FDA?
Vapocoolshot Mist received FDA 510(k) clearance on 2020-04-14, under approval number K193349.
What company makes Vapocoolshot Mist?
Vapocoolshot Mist is manufactured by Vapocoolshot, Inc..
What is the FDA product code for Vapocoolshot Mist?
The FDA product code for Vapocoolshot Mist is MLY.
Other Devices by Vapocoolshot, Inc.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.