FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
K Number: K150499
·
Decision Apr 21, 2015
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
202
Applicant Total
19
Review Days
54
Basic Information
- Device Name
- Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
- K Number
- K150499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDELA AG
- Date Received
- February 26, 2015
- 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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| K150134 | Basic, Dominant Flex, KV-6 | Apr 21, 2015 | Substantially Equivalent |
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| K141553 | MEDELA THOPAZ+ | Aug 25, 2014 | Substantially Equivalent |
| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | Oct 11, 2013 | Substantially Equivalent |
| K130210 | MEDELA THOPAZ | Mar 15, 2013 | Substantially Equivalent |
| K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Oct 1, 2012 | Substantially Equivalent |
| K080357 | MEDELA INVIA WOUND THERAPY | Jul 24, 2008 | Substantially Equivalent |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | Jul 23, 2008 | Substantially Equivalent |