EXOMIO, MODEL 2.0 SP1— 510(k) K032550
Substantially EquivalentMedcom GmbH
FDA 510(k) clearance K032550 for EXOMIO, MODEL 2.0 SP1, Substantially Equivalent on 2003-09-25. Applicant: Medcom GmbH. Device class: 2.
Clearance details
- Applicant
- Medcom GmbH
- Product code
- Code KPQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5840
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Darmstadt, Hessen, DE
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