FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZINETICS INTERNAL REFERENCE PROBE
K Number: K910694
·
Decision May 17, 1991
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
48
Applicant Total
4
Review Days
87
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
- ZINETICS INTERNAL REFERENCE PROBE
- K Number
- K910694
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Zinetics Medical, Inc.
- Date Received
- February 19, 1991
- Decision Date
- May 17, 1991
- Product Code
- FFT
- 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 |
|---|---|---|---|
| FFT | Electrode, Ph, Stomach | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFT), ordered by most recent decision date.
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
BRAVO PH MONITORING SYSTEM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PH ANALYSIS MODULE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LOT 440
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology