510(k) K000097
K000097 is an FDA 510(k) premarket notification submitted by Grason-Stadler, Inc. for the device "GSI 2000 MIDDLE EAR ANALYZER". The FDA issued a decision of Substantially Equivalent on April 12, 2000. The device falls under product code ETY (Tester, Auditory Impedance), a Class II device regulated under 21 CFR 874.1090. Grason-Stadler, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2000
- Date Received
- January 13, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Auditory Impedance
- Device Class
- Class II
- Regulation Number
- 874.1090
- Review Panel
- EN
- Submission Type