The following data is part of a premarket notification filed by Cardiodynamics International Corp. with the FDA for Modification To Bioz.com Hemodynamic Monitor.
| Device ID | K011439 |
| 510k Number | K011439 |
| Device Name: | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR |
| Classification | Plethysmograph, Impedance |
| Applicant | CARDIODYNAMICS INTERNATIONAL CORP. 6175 NANCY RIDGE DR., #300 San Diego, CA 92121 |
| Contact | Brian Park |
| Correspondent | Brian Park 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 | 2001-05-10 |
| Decision Date | 2001-11-02 |