SENSICARDIAC

510(k)K121617CardiovascularDQD

DIACOUSTIC MEDICAL (PTY) is listed for SENSICARDIAC (K121617). The FDA list gives July 27, 2012 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 DQD. 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=K121617

Official FDA database record

Date of final decision: July 27, 2012
Company on the FDA list: DIACOUSTIC MEDICAL (PTY)
Lead panel: Cardiovascular
Primary product code: DQD
openFDA device name for the code: Stethoscope, Electronic
Device class: 2
Regulation number: 870.1875
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary