SOZO
510(k)K172507CardiovascularDSB
ImpediMed Limited is listed for SOZO (K172507). The FDA list gives December 22, 2017 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DSB. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172507
- Date of final decision
- December 22, 2017
- Company on the FDA list
- ImpediMed Limited
- Lead panel
- Cardiovascular
- Primary product code
- DSB
- openFDA device name for the code
- Plethysmograph, Impedance
- Device class
- 2
- Regulation number
- 870.2770
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary