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FDA 510(k)

PAINACEA MODEL XR8 INFRARED HEAT LAMP

K-Number: K051046 · 2005-05-10

ApplicantAtlantis Luminescent Products, LLC
Decision Date2005-05-10
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PAINACEA MODEL XR8 INFRARED HEAT LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Atlantis Luminescent Products, LLC. It received FDA 510(k) clearance on 2005-05-10 under 510(k) number K051046. 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 PAINACEA MODEL XR8 INFRARED HEAT LAMP?

PAINACEA MODEL XR8 INFRARED HEAT LAMP is a medical device that received FDA 510(k) clearance on 2005-05-10. The listed applicant is Atlantis Luminescent Products, LLC. The 510(k) number is K051046.

When did PAINACEA MODEL XR8 INFRARED HEAT LAMP receive FDA 510(k) clearance?

PAINACEA MODEL XR8 INFRARED HEAT LAMP received FDA 510(k) clearance on 2005-05-10, under 510(k) number K051046.

Who is the listed applicant for PAINACEA MODEL XR8 INFRARED HEAT LAMP?

The FDA 510(k) record lists Atlantis Luminescent Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAINACEA MODEL XR8 INFRARED HEAT LAMP?

The FDA product code for PAINACEA MODEL XR8 INFRARED HEAT LAMP 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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