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

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..

Clearance details

Applicant: Airstrip Technologies, Inc.
Product code: Code MSX
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 ↗

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.