The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs Bubble Humidifier.
| Device ID | K161719 |
| 510k Number | K161719 |
| Device Name: | Salter Labs Bubble Humidifier |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | SALTER LABS 2365 CAMINO VIDA ROBLE Carlsbad, CA 92011 |
| Contact | Mara Caler |
| Correspondent | Mara Caler SALTER LABS 2365 CAMINO VIDA ROBLE Carlsbad, CA 92011 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-22 |
| Decision Date | 2017-09-21 |
| Summary: | summary |