FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
GASTROGRAPH
K Number: K903646
·
Decision Nov 5, 1990
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
48
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- GASTROGRAPH
- K Number
- K903646
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medics Instrument Corp.
- Date Received
- August 14, 1990
- Decision Date
- November 5, 1990
- 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 |
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