FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VECTOR AMBULATORY DRUG DELIVERY SYSTEM
K Number: K935461
·
Decision Apr 28, 1994
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
3
Review Days
167
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Basic Information
- Device Name
- VECTOR AMBULATORY DRUG DELIVERY SYSTEM
- K Number
- K935461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infusion Technology Intl.
- Date Received
- November 12, 1993
- Decision Date
- April 28, 1994
- Product Code
- FIH
- 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 |
|---|---|---|---|
| FIH | Pump, Infusion Or Syringe, Extra-Luminal | FDA class 2 | Gastroenterology, Urology |
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