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FDA 510(k)

MEDICOOL

K-Number: K923643 · 1993-03-31

ApplicantMicromedic Systems
Decision Date1993-03-31
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MEDICOOL is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K923643. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICOOL?

MEDICOOL is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Micromedic Systems. The 510(k) number is K923643.

When did MEDICOOL receive FDA 510(k) clearance?

MEDICOOL received FDA 510(k) clearance on 1993-03-31, under 510(k) number K923643.

Who is the listed applicant for MEDICOOL?

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

What is the FDA product code for MEDICOOL?

The FDA product code for MEDICOOL is ILO.

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Other records listing Micromedic Systems as applicant

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Related Devices (Code: ILO)

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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.

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