AirStrip ONE Web Client with Alarm Communication Management (ACM)— 510(k) K211949

Name: FDA 510(k) clearance K211949
Creator: U.S. Food and Drug Administration
Published: 2021-12-09

Substantially Equivalent

Airstrip Technologies, Inc.

FDA 510(k) clearance K211949 for AirStrip ONE Web Client with Alarm Communication Management (ACM), Substantially Equivalent on 2021-12-09. Applicant: Airstrip Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Airstrip Technologies, Inc.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2021-06-23
Decision date: 2021-12-09
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 MSX

product code MSX

Death: 59
Total: 59

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.