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FDA 510(k)

AirStrip ONE Web Client with Alarm Communication Management (ACM)

K-Number: K211949 · 2021-12-09

ApplicantAirstrip Technologies, Inc.
Decision Date2021-12-09
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AirStrip ONE Web Client with Alarm Communication Management (ACM) is a medical device manufactured by Airstrip Technologies, Inc.. It received FDA 510(k) clearance on 2021-12-09 under approval number K211949. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirStrip ONE Web Client with Alarm Communication Management (ACM)?

AirStrip ONE Web Client with Alarm Communication Management (ACM) is a medical device that received FDA 510(k) clearance on 2021-12-09. It is manufactured by Airstrip Technologies, Inc.. The 510(k) number is K211949.

When was AirStrip ONE Web Client with Alarm Communication Management (ACM) approved by the FDA?

AirStrip ONE Web Client with Alarm Communication Management (ACM) received FDA 510(k) clearance on 2021-12-09, under approval number K211949.

What company makes AirStrip ONE Web Client with Alarm Communication Management (ACM)?

AirStrip ONE Web Client with Alarm Communication Management (ACM) is manufactured by Airstrip Technologies, Inc..

What is the FDA product code for AirStrip ONE Web Client with Alarm Communication Management (ACM)?

The FDA product code for AirStrip ONE Web Client with Alarm Communication Management (ACM) is MSX.

Related Clinical Trials

NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT06341673 Impact of TTNS on Bladder Symptoms Among People With MS, A RCT RECRUITING NCT07042347 Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health RECRUITING NCT07568093 PARO-agitation-study RECRUITING NCT05811208 Use of Pupillometry for Pain Assessment in ICU Patients With Delirium COMPLETED NCT05481892 Remote Monitoring for Equity in Advancing Control of Hypertension COMPLETED

Other Devices by Airstrip Technologies, Inc.

K160862AirStrip RPM K182226AirStrip RPM InvisionHeart Adapter

Related Devices (Code: MSX)

K153156eCareManager 4.0.1Visicu, Inc. K160862AirStrip RPMAirstrip Technologies, Inc. K161164CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems K171322eCareManager 4.1Visicu, Inc. K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K180430Digistat Smart CentralAscom Ums Srl Unipersonale

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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