FDA 510(k), K182226, AirStrip RPM InvisionHeart Adapter
FDA 510(k), K182226, AirStrip RPM InvisionHeart Adapter
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510(K) Number: K182226
Device Name: AirStrip RPM InvisionHeart Adapter
Manufacturer: AirStrip Technologies, Inc.
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 08/16/2018
Decision Date: 09/11/2018
Regulation Medical Specialty: Cardiovascular
Device Name: AirStrip RPM InvisionHeart Adapter
Manufacturer: AirStrip Technologies, Inc.
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 08/16/2018
Decision Date: 09/11/2018
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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