KardioScreen— 510(k) K191692

Substantially Equivalent

Imedrix Inc. (Formerly Piitech Inc.)

FDA 510(k) clearance K191692 for KardioScreen, Substantially Equivalent on 2020-01-10. Applicant: Imedrix Inc. (Formerly Piitech Inc.).

Clearance details

Applicant: Imedrix Inc. (Formerly Piitech Inc.)
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2019-06-25
Decision date: 2020-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.