FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
K Number: K222727
·
Decision Jun 2, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
10
Applicant Total
1
Review Days
267
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Basic Information
- Device Name
- i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
- K Number
- K222727
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5665
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I3 Membrane GmbH
- Date Received
- September 8, 2022
- Decision Date
- June 2, 2023
- Product Code
- NHV
- 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 |
|---|---|---|---|
| NHV | System, Water Purification, General Medical Use | FDA class 2 | Gastroenterology, Urology |
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