Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AirStrip RPM

K-Number: K160862 · 2016-09-19

ApplicantAirstrip Technologies, Inc.
Decision Date2016-09-19
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AirStrip RPM is the device name listed in this FDA 510(k) record. The listed applicant is Airstrip Technologies, Inc.. It received FDA 510(k) clearance on 2016-09-19 under 510(k) number K160862. 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 RPM?

AirStrip RPM is a medical device that received FDA 510(k) clearance on 2016-09-19. The listed applicant is Airstrip Technologies, Inc.. The 510(k) number is K160862.

When did AirStrip RPM receive FDA 510(k) clearance?

AirStrip RPM received FDA 510(k) clearance on 2016-09-19, under 510(k) number K160862.

Who is the listed applicant for AirStrip RPM?

The FDA 510(k) record lists Airstrip Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirStrip RPM?

The FDA product code for AirStrip RPM is MSX.

Other records listing Airstrip Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)K182226AirStrip RPM InvisionHeart Adapter

Related Devices (Code: MSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.K242750Central StationNihon Kohden Digital Health Solutions, LLC

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.

↑