FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Molekule Air Pro
K Number: K211194
·
Decision Aug 20, 2021
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
35
Applicant Total
3
Review Days
121
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Basic Information
- Device Name
- Molekule Air Pro
- K Number
- K211194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6500
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Molekule, Inc.
- Date Received
- April 21, 2021
- Decision Date
- August 20, 2021
- Product Code
- FRA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRA | Purifier, Air, Ultraviolet, Medical | FDA class 2 | General Hospital |
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