HEATER BASE, MODEL PMH7000

Humidifier, Respiratory Gas, (direct Patient Interface)

PACIFIC MEDICO CO., LTD.

The following data is part of a premarket notification filed by Pacific Medico Co., Ltd. with the FDA for Heater Base, Model Pmh7000.

Pre-market Notification Details

Device IDK080149
510k NumberK080149
Device Name:HEATER BASE, MODEL PMH7000
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant PACIFIC MEDICO CO., LTD. 2-6-4HONGO, BUNKYO-KU, Tokyo,  JP 113-0033
ContactYoshimo Toyama
CorrespondentYoshimo Toyama
PACIFIC MEDICO CO., LTD. 2-6-4HONGO, BUNKYO-KU, Tokyo,  JP 113-0033
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-22
Decision Date2008-12-18
Summary:summary

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