FDA 510(k), K190208, Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

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

472 pages (800 of 1,272 original pages are fully redacted)