IMPEDANCE METER ON-1— 510(k) K823227
Substantially EquivalentKells Medical, Inc.
FDA 510(k) clearance K823227 for IMPEDANCE METER ON-1, Substantially Equivalent on 1982-11-22. Applicant: Kells Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Kells Medical, 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
- Walker, MI, US
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