Devices · MONARCH MEDICAL TECHNOLOGIES
EndoTool SubQ
510(k)K142918AnesthesiologyNDC
MONARCH MEDICAL TECHNOLOGIES is listed for EndoTool SubQ (K142918). The FDA list gives April 24, 2015 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is NDC. 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=K142918
- Date of final decision
- April 24, 2015
- Company on the FDA list
- MONARCH MEDICAL TECHNOLOGIES
- Lead panel
- Anesthesiology
- Primary product code
- NDC
- openFDA device name for the code
- Calculator, Drug Dose
- Device class
- 2
- Regulation number
- 868.1890
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary