The following data is part of a premarket notification filed by Teleflex Medical, Inc with the FDA for Comfort Flo Humidification System.
| Device ID | K162242 |
| 510k Number | K162242 |
| Device Name: | Comfort Flo Humidification System |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | TELEFLEX MEDICAL, INC 2917 WECK DRIVE Research Triangle Park, NC 27709 |
| Contact | Brian Gall |
| Correspondent | Brian Gall TELEFLEX MEDICAL, INC 2917 WECK DRIVE Research Triangle Park, NC 27709 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-10 |
| Decision Date | 2017-01-19 |
| Summary: | summary |