FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SENTIERO
K Number: K133012
·
Decision Jun 9, 2014
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
- K Number
- K133012
- 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
- September 25, 2013
- Decision Date
- June 9, 2014
- 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 |
Similar 510(k) Clearances
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Other Clearances by Path Medical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K220139 | QScreen | Aug 3, 2022 | Substantially Equivalent |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Jun 22, 2022 | Substantially Equivalent |
| K211147 | ALGO 7i | Oct 14, 2021 | Substantially Equivalent |
| K131141 | EARPROBE | Jun 27, 2013 | Substantially Equivalent |
| K100661 | EARPROBE | Jul 1, 2010 | Substantially Equivalent |