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FDA 510(k)

RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM

K-Number: K070112 · 2007-07-13

ApplicantMedcool, Inc.
Decision Date2007-07-13
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medcool, Inc.. It received FDA 510(k) clearance on 2007-07-13 under 510(k) number K070112. 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 RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM?

RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-07-13. The listed applicant is Medcool, Inc.. The 510(k) number is K070112.

When did RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2007-07-13, under 510(k) number K070112.

Who is the listed applicant for RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM?

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

What is the FDA product code for RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM?

The FDA product code for RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM is DWJ.

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Official Source

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

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