FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL SA3 ESOPHAGEAL PH ELECTRODE
K Number: K852289
·
Decision Jul 25, 1985
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
48
Applicant Total
2
Review Days
57
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Basic Information
- Device Name
- MODEL SA3 ESOPHAGEAL PH ELECTRODE
- K Number
- K852289
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- World Precision Instruments, Inc.
- Date Received
- May 29, 1985
- Decision Date
- July 25, 1985
- 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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Other Clearances by World Precision Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883869 | DERMTRODE | Sep 30, 1988 | Substantially Equivalent |