FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Melodi Prime Breast Pump
K Number: K143574
·
Decision Apr 21, 2015
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
19
Review Days
125
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Basic Information
- Device Name
- Melodi Prime Breast Pump
- K Number
- K143574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genadyne Biotechnologies, Inc.
- Date Received
- December 17, 2014
- Decision Date
- April 21, 2015
- 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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|---|---|---|---|
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| K233614 | Genadyne DUO NPWT | Dec 23, 2024 | Substantially Equivalent |
| K221888 | Genadyne Hybrid Foam Dressings | Jun 12, 2023 | Substantially Equivalent |
| K221891 | UNO Negative Pressure Wound Therapy System | Dec 14, 2022 | Substantially Equivalent |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | Jun 1, 2022 | Substantially Equivalent |
| K180840 | UNO Negative Pressure Wound Therapy System | Nov 30, 2018 | Substantially Equivalent |
| K161599 | UNO Negative Pressure Wound Therapy System | Apr 6, 2017 | Substantially Equivalent |
| K143726 | XLR8 PLUS (XLR8+) | Jun 19, 2015 | Substantially Equivalent |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | Apr 30, 2015 | Substantially Equivalent |