AIRSTRIP REMOTE PATIENT MONITORING— 510(k) K133450

Name: FDA 510(k) clearance K133450
Creator: U.S. Food and Drug Administration
Published: 2014-02-14

Substantially Equivalent

Airstrip Technologies, LP

FDA 510(k) clearance K133450 for AIRSTRIP REMOTE PATIENT MONITORING, Substantially Equivalent on 2014-02-14. Applicant: Airstrip Technologies, LP. Device class: 2.

Clearance details

Applicant: Airstrip Technologies, LP
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2013-11-11
Decision date: 2014-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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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.