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 |