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FDA 510(k)

CHILLBUSTER

K-Number: K022903 · 2002-11-27

ApplicantMicrotek Medical, Inc.
Decision Date2002-11-27
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHILLBUSTER is the device name listed in this FDA 510(k) record. The listed applicant is Microtek Medical, Inc.. It received FDA 510(k) clearance on 2002-11-27 under 510(k) number K022903. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHILLBUSTER?

CHILLBUSTER is a medical device that received FDA 510(k) clearance on 2002-11-27. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K022903.

When did CHILLBUSTER receive FDA 510(k) clearance?

CHILLBUSTER received FDA 510(k) clearance on 2002-11-27, under 510(k) number K022903.

Who is the listed applicant for CHILLBUSTER?

The FDA 510(k) record lists Microtek Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHILLBUSTER?

The FDA product code for CHILLBUSTER is DWJ.

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Other records listing Microtek Medical, Inc. as applicant

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Related Devices (Code: DWJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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