Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- MNWAnalyzer, Body Composition2Product Code
- OBHMonitor, Extracellular Fluid, Lymphedema, Extremity2Product Code
- K230530SOZO Pro2Cleared 510(K)
- K220557MoistureMeterD Compact, LymphScanner2Cleared 510(K)
- K180126SOZO2Cleared 510(K)
- K172122SOZO2Cleared 510(K)
- K143310MoisturemeterD2Cleared 510(K)
- K130338IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS2Cleared 510(K)
- K100811IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U4002Cleared 510(K)
- K080825IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U4002Cleared 510(K)
- K050415IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS2Cleared 510(K)
- OMVUltrasonic Body Composition Analyzer2Product Code
- PUHAnalyzer, Body Composition, Exempt2Product Code
- QJBAdjunct Monitor, Protein Calorie Malnutrition2Product Code
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SOZO
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K180126
- 510(k) Type
- Traditional
- Applicant
- ImpediMed Limited
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/16/2018
- Days to Decision
- 90 days
- Submission Type
- Summary