The following data is part of a premarket notification filed by Cardiodynamics International Corp. with the FDA for Bioztect Sensor And Bioztect Cable.
| Device ID | K011797 |
| 510k Number | K011797 |
| Device Name: | BIOZTECT SENSOR AND BIOZTECT CABLE |
| Classification | Plethysmograph, Impedance |
| Applicant | CARDIODYNAMICS INTERNATIONAL CORP. 6175 NANCY RIDGE DR., #300 San Diego, CA 92121 |
| Contact | Brain Park |
| Correspondent | Brain 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-08 |
| Decision Date | 2001-07-03 |
| Summary: | summary |