SOZO— 510(k) K180126
Substantially EquivalentImpediMed Limited
FDA 510(k) clearance K180126 for SOZO, Substantially Equivalent on 2018-04-16. 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
- Traditional
- Location
- Pinkenba, AU
Recent devices under product code OBH
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view allRecalls naming K180126
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180126.
Data sourced from openFDA. This site is unofficial and independent of the FDA.