The following data is part of a premarket notification filed by Wet Nose Technologies, Llc with the FDA for Audible Pressure Release Valve With Humidifier Adapter / And Oxygen Nipple.
| Device ID | K111191 |
| 510k Number | K111191 |
| Device Name: | AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE |
| Classification | Valve, Non-rebreathing |
| Applicant | WET NOSE TECHNOLOGIES, LLC 3750 2ND AVE Los Angeles, CA 90018 |
| Contact | Lionel Newman |
| Correspondent | Lionel Newman WET NOSE TECHNOLOGIES, LLC 3750 2ND AVE Los Angeles, CA 90018 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-28 |
| Decision Date | 2011-07-28 |
| Summary: | summary |