510(k) K151509
K151509 is an FDA 510(k) premarket notification submitted by Diagnostic Group, Dba Grason-Stadler for the device "GSI TympStar Pro Middle Ear Analyzer". The FDA issued a decision of Substantially Equivalent on June 25, 2015. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2015
- Date Received
- June 4, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Tester, Auditory Impedance
- Device Class
- Class II
- Regulation Number
- 874.1090
- Review Panel
- EN
- Submission Type