MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM— 510(k) K112559

Name: FDA 510(k) clearance K112559
Creator: U.S. Food and Drug Administration
Published: 2011-12-02

Substantially Equivalent

Medapps, Inc.

FDA 510(k) clearance K112559 for MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, Substantially Equivalent on 2011-12-02. Applicant: Medapps, Inc.. Device class: 2.

Clearance details

Applicant: Medapps, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2011-09-02
Decision date: 2011-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.