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FDA 510(k)

THERMIQUE

K-Number: K022097 · 2002-09-06

ApplicantParkell, Inc.
Decision Date2002-09-06
Product CodeEAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THERMIQUE is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2002-09-06 under 510(k) number K022097. The device is classified under product code EAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMIQUE?

THERMIQUE is a medical device that received FDA 510(k) clearance on 2002-09-06. The listed applicant is Parkell, Inc.. The 510(k) number is K022097.

When did THERMIQUE receive FDA 510(k) clearance?

THERMIQUE received FDA 510(k) clearance on 2002-09-06, under 510(k) number K022097.

Who is the listed applicant for THERMIQUE?

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

What is the FDA product code for THERMIQUE?

The FDA product code for THERMIQUE is EAT.

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Other records listing Parkell, Inc. as applicant

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Related Devices (Code: EAT)

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

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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