SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR
Device Facts
| Record ID | K942613 |
|---|---|
| Device Name | SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR |
| Applicant | Koven Technology, Inc. |
| Product Code | DPW · Cardiovascular |
| Decision Date | Dec 23, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.