AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING— 510(k) K112235

Substantially Equivalent

Airstrip Technologies, LP

FDA 510(k) clearance K112235 for AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING, Substantially Equivalent on 2011-08-26. Applicant: Airstrip Technologies, LP.

Clearance details

Applicant: Airstrip Technologies, LP
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2011-08-04
Decision date: 2011-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.