SOZO Pro— 510(k) K230530
Substantially EquivalentImpediMed Limited
FDA 510(k) clearance K230530 for SOZO Pro, Substantially Equivalent on 2023-05-04. Applicant: ImpediMed Limited. Device class: 2.
Clearance details
- Applicant
- ImpediMed Limited
- Product code
- Code OBH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pinkenba, AU
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