MECON X (TEN)— 510(k) K843484
Substantially EquivalentMecon Labs
FDA 510(k) clearance K843484 for MECON X (TEN), Substantially Equivalent on 1985-01-23. Applicant: Mecon Labs. Device class: 1.
Clearance details
- Applicant
- Mecon Labs
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kearney, NE, US
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