510(k) K123624
K123624 is an FDA 510(k) premarket notification submitted by Mimosa Acoustics, Inc. for the device "OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 28, 2013. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Mimosa Acoustics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2013
- Date Received
- November 23, 2012
- 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