MOBCARDIO SYSTEM— 510(k) K113234

Substantially Equivalent

Mobhealth Incorporation

FDA 510(k) clearance K113234 for MOBCARDIO SYSTEM, Substantially Equivalent on 2011-11-17. Applicant: Mobhealth Incorporation.

Clearance details

Applicant: Mobhealth Incorporation
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2011-11-02
Decision date: 2011-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temple City, 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.