FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASOGASTRIC PH SUCTION CATHETER, ST-5001
K Number: K891410
·
Decision Jun 23, 1989
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
48
Applicant Total
2
Review Days
101
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Basic Information
- Device Name
- NASOGASTRIC PH SUCTION CATHETER, ST-5001
- K Number
- K891410
- 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
- March 14, 1989
- Decision Date
- June 23, 1989
- 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 | ||
|---|---|---|---|
| K872929 | PH MONITORING SYSTEM | Aug 10, 1987 | Substantially Equivalent |