510(k) K213345
K213345 is an FDA 510(k) premarket notification submitted by Path Medical GmbH for the device "Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE". The FDA issued a decision of Substantially Equivalent on June 22, 2022. 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 22, 2022
- Date Received
- October 8, 2021
- 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