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FDA 510(k)

ARCTIC BLAST INTRAVENOUS FLUID CHILLER

K-Number: K080899 · 2008-08-07

ApplicantMedivance, Inc.
Decision Date2008-08-07
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARCTIC BLAST INTRAVENOUS FLUID CHILLER is the device name listed in this FDA 510(k) record. The listed applicant is Medivance, Inc.. It received FDA 510(k) clearance on 2008-08-07 under 510(k) number K080899. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCTIC BLAST INTRAVENOUS FLUID CHILLER?

ARCTIC BLAST INTRAVENOUS FLUID CHILLER is a medical device that received FDA 510(k) clearance on 2008-08-07. The listed applicant is Medivance, Inc.. The 510(k) number is K080899.

When did ARCTIC BLAST INTRAVENOUS FLUID CHILLER receive FDA 510(k) clearance?

ARCTIC BLAST INTRAVENOUS FLUID CHILLER received FDA 510(k) clearance on 2008-08-07, under 510(k) number K080899.

Who is the listed applicant for ARCTIC BLAST INTRAVENOUS FLUID CHILLER?

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

What is the FDA product code for ARCTIC BLAST INTRAVENOUS FLUID CHILLER?

The FDA product code for ARCTIC BLAST INTRAVENOUS FLUID CHILLER is NCX.

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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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