EARCHECK PRO— 510(k) K970685
Substantially EquivalentMdi Instruments, Inc.
FDA 510(k) clearance K970685 for EARCHECK PRO, Substantially Equivalent on 1997-05-28. Applicant: Mdi Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Mdi Instruments, 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
- Woburn, MA, US
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