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FDA 510(k)

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

K-Number: K080908 · 2008-10-17

ApplicantInnercool Therapies, Inc.- A Delaware Corporation
Decision Date2008-10-17
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innercool Therapies, Inc.- A Delaware Corporation. It received FDA 510(k) clearance on 2008-10-17 under 510(k) number K080908. 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 INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM?

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Innercool Therapies, Inc.- A Delaware Corporation. The 510(k) number is K080908.

When did INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM receive FDA 510(k) clearance?

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM received FDA 510(k) clearance on 2008-10-17, under 510(k) number K080908.

Who is the listed applicant for INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM?

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

What is the FDA product code for INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM?

The FDA product code for INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM is NCX.

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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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