FDA 510(k)

BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM

K-Number: K110104 · 2011-02-04

ApplicantCincinnati Sub-Zero Products, Inc.

Decision Date2011-02-04

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cincinnati Sub-Zero Products, Inc.. It received FDA 510(k) clearance on 2011-02-04 under 510(k) number K110104. 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 BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM?

BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-04. The listed applicant is Cincinnati Sub-Zero Products, Inc.. The 510(k) number is K110104.

When did BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM receive FDA 510(k) clearance?

BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM received FDA 510(k) clearance on 2011-02-04, under 510(k) number K110104.

Who is the listed applicant for BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM?

The FDA 510(k) record lists Cincinnati Sub-Zero Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM?

The FDA product code for BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM is DWJ.

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Other records listing Cincinnati Sub-Zero Products, 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.