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FDA 510(k)

Vapocoolshot Mist

K-Number: K193349 · 2020-04-14

ApplicantVapocoolshot, Inc.
Decision Date2020-04-14
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

Vapocoolshot Mist is the device name listed in this FDA 510(k) record. The listed applicant is Vapocoolshot, Inc.. It received FDA 510(k) clearance on 2020-04-14 under 510(k) 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. The listed applicant is Vapocoolshot, Inc.. The 510(k) number is K193349.

When did Vapocoolshot Mist receive FDA 510(k) clearance?

Vapocoolshot Mist received FDA 510(k) clearance on 2020-04-14, under 510(k) number K193349.

Who is the listed applicant for Vapocoolshot Mist?

The FDA 510(k) record lists Vapocoolshot, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vapocoolshot Mist?

The FDA product code for Vapocoolshot Mist is MLY.

Other records listing Vapocoolshot, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243654DentalJectK201248Syringe Holder accessory

Related Devices (Code: MLY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243654DentalJectVapocoolshot, Inc.K232674PainFreeze IINuance Medical, LLCK203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.K202782num Vapocoolant623 Medical, LLCK201248Syringe Holder accessoryVapocoolshot, Inc.K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayGebauer Company

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.

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