SOZO Body Fluid Analyzer— 510(k) K193410
Substantially EquivalentImpediMed Limited
FDA 510(k) clearance K193410 for SOZO Body Fluid Analyzer, Substantially Equivalent on 2020-10-02. Applicant: ImpediMed Limited. Device class: 2.
Clearance details
- Applicant
- ImpediMed Limited
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pinkenba, AU
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