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FDA 510(k)

COOLTOUCH, MODEL NS 160

K-Number: K040921 · 2004-09-28

ApplicantCooltouch, Inc.
Decision Date2004-09-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH, MODEL NS 160 is the device name listed in this FDA 510(k) record. The listed applicant is Cooltouch, Inc.. It received FDA 510(k) clearance on 2004-09-28 under 510(k) number K040921. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOLTOUCH, MODEL NS 160?

COOLTOUCH, MODEL NS 160 is a medical device that received FDA 510(k) clearance on 2004-09-28. The listed applicant is Cooltouch, Inc.. The 510(k) number is K040921.

When did COOLTOUCH, MODEL NS 160 receive FDA 510(k) clearance?

COOLTOUCH, MODEL NS 160 received FDA 510(k) clearance on 2004-09-28, under 510(k) number K040921.

Who is the listed applicant for COOLTOUCH, MODEL NS 160?

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

What is the FDA product code for COOLTOUCH, MODEL NS 160?

The FDA product code for COOLTOUCH, MODEL NS 160 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Cooltouch, 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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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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