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FDA 510(k)

INSULIN PROTECTOR

K-Number: K073555 · 2008-07-11

ApplicantMedicool, Inc.
Decision Date2008-07-11
Product CodeIQG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INSULIN PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medicool, Inc.. It received FDA 510(k) clearance on 2008-07-11 under 510(k) number K073555. The device is classified under product code IQG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSULIN PROTECTOR?

INSULIN PROTECTOR is a medical device that received FDA 510(k) clearance on 2008-07-11. The listed applicant is Medicool, Inc.. The 510(k) number is K073555.

When did INSULIN PROTECTOR receive FDA 510(k) clearance?

INSULIN PROTECTOR received FDA 510(k) clearance on 2008-07-11, under 510(k) number K073555.

Who is the listed applicant for INSULIN PROTECTOR?

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 INSULIN PROTECTOR?

The FDA product code for INSULIN PROTECTOR is IQG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K895674MEDICOOL, CONTAINER FOR STORING INSULIN

Related Devices (Code: IQG)

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.

K072174INSUCOZI INSULIN VIAL COVER41 Industries, LLCK063180ISECURE SYRINGE CARTRIDGE HOLDERHospira, Inc.

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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