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FDA 510(k), K190208, Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
FDA 510(k), K190208, Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
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510(K) Number: K190208
Device Name: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Manufacturer: Diversatek Healthcare
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 02/04/2019
Decision Date: 10/03/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Manufacturer: Diversatek Healthcare
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 02/04/2019
Decision Date: 10/03/2019
Regulation Medical Specialty: Gastroenterology/Urology
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- 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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