GSI 2000 MIDDLE EAR ANALYZER— 510(k) K000097
Substantially EquivalentGrason-Stadler, Inc.
FDA 510(k) clearance K000097 for GSI 2000 MIDDLE EAR ANALYZER, Substantially Equivalent on 2000-04-12. Applicant: Grason-Stadler, Inc.. Device class: 2.
Clearance details
- Applicant
- Grason-Stadler, Inc.
- Product code
- Code ETY
- Device class
- Class 2
- Regulation
- 21 CFR 874.1090
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Milford, NH, US
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