The following data is part of a premarket notification filed by Providence Global Medical, Inc. with the FDA for Enduravent-5 Ventilator.
| Device ID | K092263 |
| 510k Number | K092263 |
| Device Name: | ENDURAVENT-5 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PROVIDENCE GLOBAL MEDICAL, INC. 4659 SOUTH, 2300 EAST #203 Salt Lake City, UT 84117 |
| Contact | Helen Redd |
| Correspondent | Helen Redd PROVIDENCE GLOBAL MEDICAL, INC. 4659 SOUTH, 2300 EAST #203 Salt Lake City, UT 84117 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2010-01-21 |
| Summary: | summary |