The following data is part of a premarket notification filed by Cardiodynamics International Corp. with the FDA for Bioz System.
| Device ID | K963183 |
| 510k Number | K963183 |
| Device Name: | BIOZ SYSTEM |
| Classification | Plethysmograph, Impedance |
| Applicant | CARDIODYNAMICS INTERNATIONAL CORP. 6155 CORNERSTONE COURT EAST SUITE 125 San Diego, CA 92121 |
| Contact | James Barley |
| Correspondent | James Barley CARDIODYNAMICS INTERNATIONAL CORP. 6155 CORNERSTONE COURT EAST SUITE 125 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 | 1996-08-14 |
| Decision Date | 1996-11-26 |