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FDA 510(k)

GAME READY CLASSIC SYSTEM, MODEL 550550

K-Number: K072620 · 2007-10-31

ApplicantCoolsystems, Inc.
Decision Date2007-10-31
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GAME READY CLASSIC SYSTEM, MODEL 550550 is the device name listed in this FDA 510(k) record. The listed applicant is Coolsystems, Inc.. It received FDA 510(k) clearance on 2007-10-31 under 510(k) number K072620. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAME READY CLASSIC SYSTEM, MODEL 550550?

GAME READY CLASSIC SYSTEM, MODEL 550550 is a medical device that received FDA 510(k) clearance on 2007-10-31. The listed applicant is Coolsystems, Inc.. The 510(k) number is K072620.

When did GAME READY CLASSIC SYSTEM, MODEL 550550 receive FDA 510(k) clearance?

GAME READY CLASSIC SYSTEM, MODEL 550550 received FDA 510(k) clearance on 2007-10-31, under 510(k) number K072620.

Who is the listed applicant for GAME READY CLASSIC SYSTEM, MODEL 550550?

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

What is the FDA product code for GAME READY CLASSIC SYSTEM, MODEL 550550?

The FDA product code for GAME READY CLASSIC SYSTEM, MODEL 550550 is IRP.

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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Other records listing Coolsystems, 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.

K071050GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM

Related Devices (Code: IRP)

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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