The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Cardio Metrics Invasive Pressure Monit.
| Device ID | K841960 |
| 510k Number | K841960 |
| Device Name: | CARDIO METRICS INVASIVE PRESSURE MONIT |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar, FL 34677 -0137 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-14 |
| Decision Date | 1985-11-08 |