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FDA 510(k)

PRN THERMALCARE, MODEL 3000

K-Number: K062794 · 2006-12-07

ApplicantAmerican Healthcare Products, Inc.
Decision Date2006-12-07
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRN THERMALCARE, MODEL 3000 is the device name listed in this FDA 510(k) record. The listed applicant is American Healthcare Products, Inc.. It received FDA 510(k) clearance on 2006-12-07 under 510(k) number K062794. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRN THERMALCARE, MODEL 3000?

PRN THERMALCARE, MODEL 3000 is a medical device that received FDA 510(k) clearance on 2006-12-07. The listed applicant is American Healthcare Products, Inc.. The 510(k) number is K062794.

When did PRN THERMALCARE, MODEL 3000 receive FDA 510(k) clearance?

PRN THERMALCARE, MODEL 3000 received FDA 510(k) clearance on 2006-12-07, under 510(k) number K062794.

Who is the listed applicant for PRN THERMALCARE, MODEL 3000?

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

What is the FDA product code for PRN THERMALCARE, MODEL 3000?

The FDA product code for PRN THERMALCARE, MODEL 3000 is DWJ.

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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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