Chillbuster
FDA 510(k) K022903 · Microtek Medical, Inc.
510(k) numberK022903
Submission
- Device name
- Chillbuster
- Applicant
- Microtek Medical, Inc.
Columbus, MS, US - Received
- September 3, 2002
- Decision date
- November 27, 2002
- 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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| K102971 | Freedomaire III Surgical Helmet System Model 10322STKFYA · Traditional | 02/23/2011SE |
| K062899 | Microtek Medical Surgical Gown/TogaFYA · Traditional | 01/25/2007SE |
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| K050322 | Microtek Equipment DrapesKKX · Traditional | 05/17/2005SE |
| K020956 | Vivosonic Dianostic Ultrasound Imaging Coupling MediaMUI · Traditional | 05/16/2002SE |
| K011318 | Venodyne DVT Advantage PlusJOW · Traditional | 10/25/2001SE |
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Questions and answers
When was Chillbuster cleared by the FDA?
Chillbuster (K022903) received a 510(k) decision of Substantially Equivalent on November 27, 2002, 85 days after the submission was received.
What is the product code of K022903?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.