510(k) BK010045
- Device
- Blood And Plasma Warming Devices
- Applicant
- Sarstedt, Inc.
- 510(k) number
- BK010045
- Product code
- KZL
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2001-12-21
- Date received
- 2001-10-29
- Regulation
- 864.9205
- Classification name
- Device, Warming. Blood And Plasma
- 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) Abbrevia
- Third party reviewed
- No
Other 510(k) Records For Product Code KZL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K813489 | ROCKING/CIRCULATING CYTO-THERM II 3570 | Cryosan, Inc. | 1982-03-04 |
| K812311 | CIRCULATING CYTO-THERMS | Cryosan, Inc. | 1981-09-16 |
| K800699 | FLO TEM (FLUID WARNER) | Chroma Products, Inc. | 1980-05-08 |
| K790936 | MODEL 114 TREONIC H150 HAEMOHEATER | Vickers America Medical Corp. | 1979-09-04 |
Legacy Summary#
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FDA Review#
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