MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)— 510(k) K863353
Substantially EquivalentGrason-Stadler, Inc.
FDA 510(k) clearance K863353 for MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER), Substantially Equivalent on 1986-11-03. 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
- Traditional
- Location
- Littleton, MA, US
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