FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
imani i2
K Number: K202037
·
Decision Mar 1, 2021
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
202
Applicant Total
3
Review Days
221
Basic Information
- Device Name
- imani i2
- K Number
- K202037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- imani Co.
- Date Received
- July 23, 2020
- Decision Date
- March 1, 2021
- Product Code
- HGX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGX | Pump, Breast, Powered | FDA class 2 | Obstetrics/Gynecology |
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