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FDA 510(k)

TROPI-COOL

K-Number: K902756 · 1990-10-22

ApplicantSeabrook Medical Systems, Inc.
Decision Date1990-10-22
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TROPI-COOL is the device name listed in this FDA 510(k) record. The listed applicant is Seabrook Medical Systems, Inc.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K902756. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROPI-COOL?

TROPI-COOL is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Seabrook Medical Systems, Inc.. The 510(k) number is K902756.

When did TROPI-COOL receive FDA 510(k) clearance?

TROPI-COOL received FDA 510(k) clearance on 1990-10-22, under 510(k) number K902756.

Who is the listed applicant for TROPI-COOL?

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

What is the FDA product code for TROPI-COOL?

The FDA product code for TROPI-COOL is DWJ.

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Other records listing Seabrook Medical Systems, 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.

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Related Devices (Code: DWJ)

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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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