The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Matrx Hope(r) 5 Resuscitator.
| Device ID | K921982 |
| 510k Number | K921982 |
| Device Name: | MATRX HOPE(R) 5 RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Contact | Michael Swart |
| Correspondent | Michael Swart MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1994-10-28 |