FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
DC-Air and Athlos-1 and Athlos-Air
K Number: K211688
·
Decision Jul 22, 2021
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
201
Applicant Total
1
Review Days
50
Basic Information
- Device Name
- DC-Air and Athlos-1 and Athlos-Air
- K Number
- K211688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Athlos Oy
- Date Received
- June 2, 2021
- Decision Date
- July 22, 2021
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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