510(k) K123701
K123701 is an FDA 510(k) premarket notification submitted by Frye Electronics, Inc. for the device "HEARLAB ACA". The FDA issued a decision of Substantially Equivalent on April 5, 2013. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Frye Electronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2013
- Date Received
- December 3, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Auditory, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1900
- Review Panel
- NE
- Submission Type