Eko Analysis Software
510(k)K192004CardiovascularMWI
Eko Devices Inc is listed for Eko Analysis Software (K192004). The FDA list gives January 15, 2020 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 MWI. 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=K192004
- Date of final decision
- January 15, 2020
- Company on the FDA list
- Eko Devices Inc
- Lead panel
- Cardiovascular
- Primary product code
- MWI
- openFDA device name for the code
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- 2
- Regulation number
- 870.2300
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary