510(k) BK180254
- Device
- Processing Systems For Frozen Blood
- Applicant
- Fresenius Kabi AG
- 510(k) number
- BK180254
- Product code
- KSW
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2018-12-03
- Date received
- 2018-09-04
- Regulation
- 864.9145
- Classification name
- System, Processing For Frozen Blood
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code KSW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760914 | DOUBLE ELUTRA-PACK UNIT | Travenol Laboratories, S.A. | 1976-11-23 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases