FDA 510(k)

AirStrip RPM InvisionHeart Adapter

K-Number: K182226 · 2018-09-11

Decision Date2018-09-11

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AirStrip RPM InvisionHeart Adapter is a medical device manufactured by Airstrip Technologies, Inc.. It received FDA 510(k) clearance on 2018-09-11 under approval number K182226. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirStrip RPM InvisionHeart Adapter?

AirStrip RPM InvisionHeart Adapter is a medical device that received FDA 510(k) clearance on 2018-09-11. It is manufactured by Airstrip Technologies, Inc.. The 510(k) number is K182226.

When was AirStrip RPM InvisionHeart Adapter approved by the FDA?

AirStrip RPM InvisionHeart Adapter received FDA 510(k) clearance on 2018-09-11, under approval number K182226.

What company makes AirStrip RPM InvisionHeart Adapter?

AirStrip RPM InvisionHeart Adapter is manufactured by Airstrip Technologies, Inc..

What is the FDA product code for AirStrip RPM InvisionHeart Adapter?

The FDA product code for AirStrip RPM InvisionHeart Adapter is MWI.

Other Devices by Airstrip Technologies, Inc.

K160862AirStrip RPM K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)

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Official Source

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