The following data is part of a premarket notification filed by Cardiodynamics International Corp. with the FDA for Bioz Dx Hemodynamic Monitor With Philips 12-lead Ecg, Model 5100.
| Device ID | K070156 |
| 510k Number | K070156 |
| Device Name: | BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 |
| Classification | Plethysmograph, Impedance |
| Applicant | CARDIODYNAMICS INTERNATIONAL CORP. 6175 NANCY RIDGE DR., #300 San Diego, CA 92121 |
| Contact | Paul L Shaffer |
| Correspondent | Paul L Shaffer 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 | 2007-01-17 |
| Decision Date | 2007-09-26 |
| Summary: | summary |