FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
K Number: K190208
·
Decision Oct 3, 2019
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
68
Applicant Total
3
Review Days
241
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
- K Number
- K190208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diversatek Healthcare
- Date Received
- February 4, 2019
- Decision Date
- October 3, 2019
- Product Code
- FFX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFX), ordered by most recent decision date.
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Solar Compact (G4-1)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EndoflipTM 300 System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EndoflipTM 300
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Transit-Pellets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IntraMarX 3D Radiopaque Marker
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology