AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING— 510(k) K122133

Name: FDA 510(k) clearance K122133
Creator: U.S. Food and Drug Administration
Published: 2012-10-02

Substantially Equivalent

Airstrip Technologies, LP

FDA 510(k) clearance K122133 for AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING, Substantially Equivalent on 2012-10-02. 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: 2012-07-18
Decision date: 2012-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Airstrip Technologies, LP

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K133450 — AIRSTRIP REMOTE PATIENT MONITORING2014-02-14
K133394 — AIRSTRIP REMOTE PATIENT MONITORING2014-02-06
K131786 — AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER2013-07-03
K121871 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING2012-07-03
K112235 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING2011-08-26

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.