FDA 510(k), K190090, DynoSense Vital Sign Measuring System
FDA 510(k), K190090, DynoSense Vital Sign Measuring System
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510(K) Number: K190090
Device Name: DynoSense Vital Sign Measuring System
Manufacturer: Saeed Azimi
Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation Number: MWI
Classification Product Code: 01/17/2019
Date Received: 08/02/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: DynoSense Vital Sign Measuring System
Manufacturer: Saeed Azimi
Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation Number: MWI
Classification Product Code: 01/17/2019
Date Received: 08/02/2019
Decision Date: Substantially Equivalent (SESE)
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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