The following data is part of a premarket notification filed by Pacific Medico Co., Ltd. with the FDA for Respiratory Gas Humidifier.
| Device ID | K132857 |
| 510k Number | K132857 |
| Device Name: | RESPIRATORY GAS HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | PACIFIC MEDICO CO., LTD. 2-6-4 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Contact | Yoshio Toyama |
| Correspondent | Yoshio Toyama PACIFIC MEDICO CO., LTD. 2-6-4 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-12 |
| Decision Date | 2014-05-01 |
| Summary: | summary |