The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Matrx Disposable Non-invasive Gelled Pacing Elec..
| Device ID | K900551 |
| 510k Number | K900551 |
| Device Name: | MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Contact | Wynne, P.e. |
| Correspondent | Wynne, P.e. MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-06 |
| Decision Date | 1990-05-09 |