Bair Hugger Temperature Management System
FDA 510(k) K041686 · Arizant Healthcare, Inc.
510(k) numberK041686
Submission
- Device name
- Bair Hugger Temperature Management System
- Applicant
- Arizant Healthcare, Inc.
Eden Prairie, MN, US - Received
- June 22, 2004
- Decision date
- June 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from Care Essentials Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K120412 | 3M Spoton Temperature Monitoring SystemFLL · Traditional | 05/30/2012SE |
| K082217 | Ranger Rapid Flow Blood/Fluid Warming SystemLGZ · Traditional | 10/06/2008SE |
| K060939 | Ranger Irrigation Fluid Warming SystemLGZ · Traditional | 06/26/2006SE |
| K060865 | Bair Paws Temperature Management System Model 850DWJ · Special | 04/24/2006SE |
| K053645 | Modification To:Bair Hugger Temperature Management SystemsDWJ · Special | 03/09/2006SE |
Questions and answers
When was Bair Hugger Temperature Management System cleared by the FDA?
Bair Hugger Temperature Management System (K041686) received a 510(k) decision of Substantially Equivalent on June 30, 2004, 8 days after the submission was received.
What is the product code of K041686?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.