Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty— 510(k) K150499
Substantially EquivalentMedela AG
FDA 510(k) clearance K150499 for Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty, Substantially Equivalent on 2015-04-21. Applicant: Medela AG. Device class: 2.
Clearance details
- Applicant
- Medela AG
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baar, CH
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More clearances from Medela AG
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.