FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Powered Breast Pump (Models 7V and 7X)
K Number: K211016
·
Decision Jun 29, 2022
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
1
Review Days
450
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Basic Information
- Device Name
- Powered Breast Pump (Models 7V and 7X)
- K Number
- K211016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haenim Co., Ltd.
- Date Received
- April 5, 2021
- Decision Date
- June 29, 2022
- 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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