The following data is part of a premarket notification filed by Pattient Safety Innovations, Llp with the FDA for Ox-sox, Model C, D, E,.
| Device ID | K062300 |
| 510k Number | K062300 |
| Device Name: | OX-SOX, MODEL C, D, E, |
| Classification | Cylinder, Compressed Gas, And Valve |
| Applicant | PATTIENT SAFETY INNOVATIONS, LLP 10051 E HIGHLAND RD SUITE 29-202 Howell, MI 48843 -6317 |
| Contact | Erik Stalhandske |
| Correspondent | Erik Stalhandske PATTIENT SAFETY INNOVATIONS, LLP 10051 E HIGHLAND RD SUITE 29-202 Howell, MI 48843 -6317 |
| Product Code | ECX |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-11-27 |