FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Smart One
K Number: K181666
·
Decision Aug 1, 2018
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
78
Applicant Total
1
Review Days
37
Basic Information
- Device Name
- Smart One
- K Number
- K181666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MIR Medical International Research
- Date Received
- June 25, 2018
- Decision Date
- August 1, 2018
- Product Code
- BZH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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