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FDA 510(k)

HEATER BASE, MODEL PMH7000

K-Number: K080149 · 2008-12-18

ApplicantPacific Medico Co., Ltd.
Decision Date2008-12-18
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEATER BASE, MODEL PMH7000 is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Medico Co., Ltd.. It received FDA 510(k) clearance on 2008-12-18 under 510(k) number K080149. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEATER BASE, MODEL PMH7000?

HEATER BASE, MODEL PMH7000 is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is Pacific Medico Co., Ltd.. The 510(k) number is K080149.

When did HEATER BASE, MODEL PMH7000 receive FDA 510(k) clearance?

HEATER BASE, MODEL PMH7000 received FDA 510(k) clearance on 2008-12-18, under 510(k) number K080149.

Who is the listed applicant for HEATER BASE, MODEL PMH7000?

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

What is the FDA product code for HEATER BASE, MODEL PMH7000?

The FDA product code for HEATER BASE, MODEL PMH7000 is BTT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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