Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads
FDA 510(k) K033021 · Kimberly-Clark Corp.
510(k) numberK033021
Submission
- Device name
- Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads
- Applicant
- Kimberly-Clark Corp.
Roswell, GA, US - Received
- September 26, 2003
- Decision date
- November 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads cleared by the FDA?
Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads (K033021) received a 510(k) decision of Substantially Equivalent on November 12, 2003, 47 days after the submission was received.
What is the product code of K033021?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.