Blood/Fluid Warmer Model DW-1000A
FDA 510(k) K770232 · Gorman Rupp Industries
510(k) numberK770232
Submission
- Device name
- Blood/Fluid Warmer Model DW-1000A
- Applicant
- Gorman Rupp Industries
Mchenry, IL, US - Received
- February 7, 1977
- Decision date
- February 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSB – Warmer, Blood, Non-Electromagnetic Radiation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9205
- Specialty
- Hematology
Other 510(k)s with product code BSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112639 | The Belmont Buddy Lite Fluid WarmerBSB · Special | Belmont Instrument Corp. | 11/16/2011SE |
| K090508 | The Belmont Buddy Lite Fluid WarmerBSB · Special | Belmont Instrument Corp. | 03/26/2009SE |
| K062774 | Belmont Buddy Plus Fluid WarmerBSB · Special | Belmont Instrument Corp. | 10/19/2006SE |
| K052547 | Belmont Buddy Fluid WarmerBSB · Special | Belmont Instrument Corp. | 10/13/2005SE |
| K031478 | MicroheaterBSB · Traditional | Belmont Instrument Corp. | 07/02/2003SE |
| K020060 | AstofloBSB · Abbreviated | Nats Corp. | 03/05/2002SE |
| K012031 | Modification to Thermal AngelBSB · Special | Estill Medical Technologies, Inc. | 07/26/2001SE |
| K991159 | Prismatherm II, AstolineBSB · Abbreviated | Stihler Electronic GmbH | 09/03/1999SE |
| K991160 | Astotherm Plus, Astotubes, AstolineBSB · Abbreviated | Stihler Electronic GmbH | 09/02/1999SE |
| K984640 | Thermal AngelBSB · Traditional | Estill Medical Technologies, Inc. | 07/01/1999SE |
More from Estill Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K771537 | Aquamatic K-Module Model K-20DWJ · Traditional | 09/06/1977SE |
| K770839 | Aquamatic K-77DWJ · Traditional | 06/08/1977SE |
| K761337 | Aquamatic K-Module Model K-10JRR · Traditional | 01/10/1977SE |
| K760910 | Disposable K-PadsILO · Traditional | 12/16/1976SE |
| K761087 | Electronic Control UnitDWJ · Traditional | 12/06/1976SE |
Questions and answers
When was Blood/Fluid Warmer Model DW-1000A cleared by the FDA?
Blood/Fluid Warmer Model DW-1000A (K770232) received a 510(k) decision of Substantially Equivalent on February 14, 1977, 7 days after the submission was received.
What is the product code of K770232?
The FDA product code is BSB – Warmer, Blood, Non-Electromagnetic Radiation, a Class II (moderate risk) device regulated under 21 CFR 864.9205.