510(k) K141524
K141524 is an FDA 510(k) premarket notification submitted by Teleemg, LLC USA for the device "NEURO-AUDIO". The FDA issued a decision of Substantially Equivalent on March 12, 2015. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Teleemg, LLC USA has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2015
- Date Received
- June 9, 2014
- 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