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FDA 510(k)

MEDICOOL, CONTAINER FOR STORING INSULIN

K-Number: K895674 · 1990-01-11

ApplicantMedicool, Inc.
Decision Date1990-01-11
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDICOOL, CONTAINER FOR STORING INSULIN is the device name listed in this FDA 510(k) record. The listed applicant is Medicool, Inc.. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K895674. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICOOL, CONTAINER FOR STORING INSULIN?

MEDICOOL, CONTAINER FOR STORING INSULIN is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is Medicool, Inc.. The 510(k) number is K895674.

When did MEDICOOL, CONTAINER FOR STORING INSULIN receive FDA 510(k) clearance?

MEDICOOL, CONTAINER FOR STORING INSULIN received FDA 510(k) clearance on 1990-01-11, under 510(k) number K895674.

Who is the listed applicant for MEDICOOL, CONTAINER FOR STORING INSULIN?

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

What is the FDA product code for MEDICOOL, CONTAINER FOR STORING INSULIN?

The FDA product code for MEDICOOL, CONTAINER FOR STORING INSULIN is LDQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Medicool, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073555INSULIN PROTECTOR

Related Devices (Code: LDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., Inc.

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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