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FDA 510(k)

MEDICOOL (MODIFICATON)

K-Number: K954095 · 1996-03-06

ApplicantMicroclimate Systems, Inc.
Decision Date1996-03-06
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

MEDICOOL (MODIFICATON) is the device name listed in this FDA 510(k) record. The listed applicant is Microclimate Systems, Inc.. It received FDA 510(k) clearance on 1996-03-06 under 510(k) number K954095. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MEDICOOL (MODIFICATON)?

MEDICOOL (MODIFICATON) is a medical device that received FDA 510(k) clearance on 1996-03-06. The listed applicant is Microclimate Systems, Inc.. The 510(k) number is K954095.

When did MEDICOOL (MODIFICATON) receive FDA 510(k) clearance?

MEDICOOL (MODIFICATON) received FDA 510(k) clearance on 1996-03-06, under 510(k) number K954095.

Who is the listed applicant for MEDICOOL (MODIFICATON)?

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

What is the FDA product code for MEDICOOL (MODIFICATON)?

The FDA product code for MEDICOOL (MODIFICATON) is ILO.

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Related Devices (Code: ILO)

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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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