The following data is part of a premarket notification filed by Cardiodynamics International Corp. with the FDA for Bioz.pc Hemodynamic Monitor Model Bz-500/bz-501; Bioz.pc User Software Installation Kit Model Bz-810.
| Device ID | K001081 |
| 510k Number | K001081 |
| Device Name: | BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 |
| 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 | 2000-04-04 |
| Decision Date | 2000-06-30 |