The following data is part of a premarket notification filed by 12th Man Technologies, Inc. with the FDA for Bigeasy Non-rebreathing Valve.
| Device ID | K142402 |
| 510k Number | K142402 |
| Device Name: | BigEasy Non-Rebreathing Valve |
| Classification | Valve, Non-rebreathing |
| Applicant | 12th Man Technologies, Inc. 7245 Garden Grove Blvd., Suite C Garden Grove, CA 92841 |
| Contact | Alex Stenzler |
| Correspondent | Alex Stenzler 12th Man Technologies, Inc. 7245 Garden Grove Blvd., Suite C Garden Grove, CA 92841 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2015-03-23 |
| Summary: | summary |