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FDA 510(k)

HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL

K-Number: K063568 · 2007-03-22

ApplicantSuzhou Medical Appliance Factory
Decision Date2007-03-22
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Medical Appliance Factory. It received FDA 510(k) clearance on 2007-03-22 under 510(k) number K063568. 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 HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL?

HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL is a medical device that received FDA 510(k) clearance on 2007-03-22. The listed applicant is Suzhou Medical Appliance Factory. The 510(k) number is K063568.

When did HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL receive FDA 510(k) clearance?

HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL received FDA 510(k) clearance on 2007-03-22, under 510(k) number K063568.

Who is the listed applicant for HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL?

The FDA 510(k) record lists Suzhou Medical Appliance Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL?

The FDA product code for HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL 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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