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FDA 510(k)

SMOOTHCOOL

K-Number: K092326 · 2010-03-05

ApplicantJeisys Medical, Inc.
Decision Date2010-03-05
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMOOTHCOOL is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K092326. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMOOTHCOOL?

SMOOTHCOOL is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K092326.

When did SMOOTHCOOL receive FDA 510(k) clearance?

SMOOTHCOOL received FDA 510(k) clearance on 2010-03-05, under 510(k) number K092326.

Who is the listed applicant for SMOOTHCOOL?

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

What is the FDA product code for SMOOTHCOOL?

The FDA product code for SMOOTHCOOL is ONF.

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Other records listing Jeisys Medical, 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: ONF)

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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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