FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
K Number: K213345
·
Decision Jun 22, 2022
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
6
Review Days
257
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Basic Information
- Device Name
- Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
- K Number
- K213345
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Path Medical GmbH
- Date Received
- October 8, 2021
- Decision Date
- June 22, 2022
- Product Code
- EWO
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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