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 |