FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WHITE RIVER AUTOMATIC BREAST PUMP
K Number: K964679
·
Decision Jun 10, 1997
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
202
Applicant Total
3
Review Days
201
Basic Information
- Device Name
- WHITE RIVER AUTOMATIC BREAST PUMP
- K Number
- K964679
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- WHITE RIVER CONCEPTS
- Date Received
- November 21, 1996
- Decision Date
- June 10, 1997
- 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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