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FDA 510(k)

THERMOTEX PLATINUM SYSTEM

K-Number: K092589 · 2010-01-28

ApplicantEas Consulting Group, LLC
Decision Date2010-01-28
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMOTEX PLATINUM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eas Consulting Group, LLC. It received FDA 510(k) clearance on 2010-01-28 under 510(k) number K092589. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOTEX PLATINUM SYSTEM?

THERMOTEX PLATINUM SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-28. The listed applicant is Eas Consulting Group, LLC. The 510(k) number is K092589.

When did THERMOTEX PLATINUM SYSTEM receive FDA 510(k) clearance?

THERMOTEX PLATINUM SYSTEM received FDA 510(k) clearance on 2010-01-28, under 510(k) number K092589.

Who is the listed applicant for THERMOTEX PLATINUM SYSTEM?

The FDA 510(k) record lists Eas Consulting Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOTEX PLATINUM SYSTEM?

The FDA product code for THERMOTEX PLATINUM SYSTEM is ILY.

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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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