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FDA 510(k)

THERMALIGHT 2000

K-Number: K992630 · 1999-09-10

ApplicantJennifermaxx, Inc.
Decision Date1999-09-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERMALIGHT 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Jennifermaxx, Inc.. It received FDA 510(k) clearance on 1999-09-10 under 510(k) number K992630. 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 THERMALIGHT 2000?

THERMALIGHT 2000 is a medical device that received FDA 510(k) clearance on 1999-09-10. The listed applicant is Jennifermaxx, Inc.. The 510(k) number is K992630.

When did THERMALIGHT 2000 receive FDA 510(k) clearance?

THERMALIGHT 2000 received FDA 510(k) clearance on 1999-09-10, under 510(k) number K992630.

Who is the listed applicant for THERMALIGHT 2000?

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

What is the FDA product code for THERMALIGHT 2000?

The FDA product code for THERMALIGHT 2000 is GEX. This falls under the Gastroenterology category.

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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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