The following data is part of a premarket notification filed by Pacific Medico Co., Ltd. with the FDA for Heater Base, Model Pmh7000.
Device ID | K080149 |
510k Number | K080149 |
Device Name: | HEATER BASE, MODEL PMH7000 |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | PACIFIC MEDICO CO., LTD. 2-6-4HONGO, BUNKYO-KU, Tokyo, JP 113-0033 |
Contact | Yoshimo Toyama |
Correspondent | Yoshimo Toyama PACIFIC MEDICO CO., LTD. 2-6-4HONGO, BUNKYO-KU, Tokyo, JP 113-0033 |
Product Code | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-22 |
Decision Date | 2008-12-18 |
Summary: | summary |