510(k) K133012
K133012 is an FDA 510(k) premarket notification submitted by Path Medical GmbH for the device "SENTIERO". The FDA issued a decision of Substantially Equivalent on June 9, 2014. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Path Medical GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2014
- Date Received
- September 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type