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FDA 510(k)

THERAGEM PROFESSIONAL T1002

K-Number: K081505 · 2008-11-19

ApplicantMedica Health, Ltd.
Decision Date2008-11-19
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERAGEM PROFESSIONAL T1002 is the device name listed in this FDA 510(k) record. The listed applicant is Medica Health, Ltd.. It received FDA 510(k) clearance on 2008-11-19 under 510(k) number K081505. 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 THERAGEM PROFESSIONAL T1002?

THERAGEM PROFESSIONAL T1002 is a medical device that received FDA 510(k) clearance on 2008-11-19. The listed applicant is Medica Health, Ltd.. The 510(k) number is K081505.

When did THERAGEM PROFESSIONAL T1002 receive FDA 510(k) clearance?

THERAGEM PROFESSIONAL T1002 received FDA 510(k) clearance on 2008-11-19, under 510(k) number K081505.

Who is the listed applicant for THERAGEM PROFESSIONAL T1002?

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

What is the FDA product code for THERAGEM PROFESSIONAL T1002?

The FDA product code for THERAGEM PROFESSIONAL T1002 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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