MAICO MB 11 WITH BERAPHONE PROBE— 510(k) K082035
Substantially EquivalentMaico Diagnostics
FDA 510(k) clearance K082035 for MAICO MB 11 WITH BERAPHONE PROBE, Substantially Equivalent on 2009-01-29. Applicant: Maico Diagnostics. Device class: 2.
Clearance details
- Applicant
- Maico Diagnostics
- Product code
- Code GWJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnesota, MN, US
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