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FDA 510(k)

CELSIUS CONTROL SYSTEM

K-Number: K033623 · 2004-05-21

ApplicantInnercool Therapies, Inc.
Decision Date2004-05-21
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CELSIUS CONTROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innercool Therapies, Inc.. It received FDA 510(k) clearance on 2004-05-21 under 510(k) number K033623. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELSIUS CONTROL SYSTEM?

CELSIUS CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-21. The listed applicant is Innercool Therapies, Inc.. The 510(k) number is K033623.

When did CELSIUS CONTROL SYSTEM receive FDA 510(k) clearance?

CELSIUS CONTROL SYSTEM received FDA 510(k) clearance on 2004-05-21, under 510(k) number K033623.

Who is the listed applicant for CELSIUS CONTROL SYSTEM?

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

What is the FDA product code for CELSIUS CONTROL SYSTEM?

The FDA product code for CELSIUS CONTROL SYSTEM is NCX.

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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Related Devices (Code: NCX)

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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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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