510(k) K980533
K980533 is an FDA 510(k) premarket notification submitted by Etymotic Research for the device "ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)". The FDA issued a decision of Substantially Equivalent on March 23, 1998. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Etymotic Research has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1998
- Date Received
- February 11, 1998
- 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