FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K Number: K993778
·
Decision Jan 6, 2000
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
90
Applicant Total
51
Review Days
59
Basic Information
- Device Name
- HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
- K Number
- K993778
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NORTHGATE TECHNOLOGIES, INC.
- Date Received
- November 8, 1999
- Decision Date
- January 6, 2000
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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