COMPLETE CONTROL System Gen2
510(k)K191083NeurologyGXY
Coapt, LLC is listed for COMPLETE CONTROL System Gen2 (K191083). The FDA list gives May 24, 2019 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is GXY. 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=K191083
- Date of final decision
- May 24, 2019
- Company on the FDA list
- Coapt, LLC
- Lead panel
- Neurology
- Primary product code
- GXY
- openFDA device name for the code
- Electrode, Cutaneous
- Device class
- 2
- Regulation number
- 882.1320
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary