FDA 510(k)
FDA unclassified
Substantially Equivalent
🇩🇪 Germany
Thermeo System
K Number: K212017
·
Decision Apr 8, 2022
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
4
Review Days
284
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Basic Information
- Device Name
- Thermeo System
- K Number
- K212017
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pro3Dure Medical GmbH
- Date Received
- June 28, 2021
- Decision Date
- April 8, 2022
- Product Code
- MQC
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| MQC | Mouthguard, Prescription | FDA unclassified | Unknown |
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