510(k) K150491
K150491 is an FDA 510(k) premarket notification submitted by Etymotic Research, Inc. for the device "ER36 Series OAE Test System". The FDA issued a decision of Substantially Equivalent on March 26, 2015. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Etymotic Research, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2015
- Date Received
- February 25, 2015
- Clearance Type
- Special
- 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