FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Vapocoolshot Mist
K Number: K193349
·
Decision Apr 14, 2020
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
22
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- Vapocoolshot Mist
- K Number
- K193349
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vapocoolshot, Inc.
- Date Received
- December 3, 2019
- Decision Date
- April 14, 2020
- Product Code
- MLY
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MLY | Vapocoolant Device | FDA unclassified | Unknown |
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