The following data is part of a premarket notification filed by Cardio Metrics, Inc. with the FDA for Perfusion Monitor.
| Device ID | K900860 |
| 510k Number | K900860 |
| Device Name: | PERFUSION MONITOR |
| Classification | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Applicant | CARDIO METRICS, INC. 525 JULIE RIVERS DR. STE.100 Sugar Land, TX 77478 |
| Contact | R Wilkinson |
| Correspondent | R Wilkinson CARDIO METRICS, INC. 525 JULIE RIVERS DR. STE.100 Sugar Land, TX 77478 |
| Product Code | DTY |
| CFR Regulation Number | 870.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-23 |
| Decision Date | 1990-08-14 |