FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PH MONITORING SYSTEM
K Number: K872929
·
Decision Aug 10, 1987
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
48
Applicant Total
2
Review Days
14
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Basic Information
- Device Name
- PH MONITORING SYSTEM
- K Number
- K872929
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Sensatronix Medical Systems, Inc.
- Date Received
- July 27, 1987
- Decision Date
- August 10, 1987
- 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 Sensatronix Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K891410 | NASOGASTRIC PH SUCTION CATHETER, ST-5001 | Jun 23, 1989 | Substantially Equivalent |