The following data is part of a premarket notification filed by Cardiodynamics International Corp. with the FDA for Biozdx Hemodynamic Monitor And 12-lead Ecg.
| Device ID | K051228 |
| 510k Number | K051228 |
| Device Name: | BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG |
| Classification | Plethysmograph, Impedance |
| Applicant | CARDIODYNAMICS INTERNATIONAL CORP. 6175 NANCY RIDGE DR., #300 San Diego, CA 92121 |
| Contact | Dennis Hepp |
| Correspondent | Dennis Hepp CARDIODYNAMICS INTERNATIONAL CORP. 6175 NANCY RIDGE DR., #300 San Diego, CA 92121 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-13 |
| Decision Date | 2005-06-10 |
| Summary: | summary |