SENTIERO
FDA 510(k) clearance K133012 · decided 2014-06-09
Clearance details
- K-number
- K133012
- Device name
- SENTIERO
- Applicant
- Path Medical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2013-09-25
- Decision date
- 2014-06-09
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- EWO
- Device class
- 2
- Regulation number
- 874.1050
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Germering, Bavaria, DE
- Third-party review
- No
- Expedited review
- No
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