FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
K Number: K180236
·
Decision Jan 18, 2019
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
1
Review Days
354
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Basic Information
- Device Name
- VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
- K Number
- K180236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vr Medical Technology Co., Ltd.
- Date Received
- January 29, 2018
- Decision Date
- January 18, 2019
- Product Code
- FPD
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
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