FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
FUJIFILM Double Balloon Endoscope EI580BT
K Number: K183032
·
Decision Jun 24, 2019
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
19
Applicant Total
64
Review Days
235
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Basic Information
- Device Name
- FUJIFILM Double Balloon Endoscope EI580BT
- K Number
- K183032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Corporation
- Date Received
- November 1, 2018
- Decision Date
- June 24, 2019
- Product Code
- FDA
- 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 |
|---|---|---|---|
| FDA | Enteroscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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