FDA 510(k)

INSU COOL

K-Number: K885055 · 1989-04-26

Decision Date1989-04-26

Product CodeLDQ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INSU COOL is the device name listed in this FDA 510(k) record. The listed applicant is Dynex Trading Co.. It received FDA 510(k) clearance on 1989-04-26 under 510(k) number K885055. 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 INSU COOL?

INSU COOL is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is Dynex Trading Co.. The 510(k) number is K885055.

When did INSU COOL receive FDA 510(k) clearance?

INSU COOL received FDA 510(k) clearance on 1989-04-26, under 510(k) number K885055.

Who is the listed applicant for INSU COOL?

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

What is the FDA product code for INSU COOL?

The FDA product code for INSU COOL is LDQ.

Other records listing Dynex Trading Co. 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.

K882731TAB PAK

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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.