Cardiodynamics International Corp.
San Diego, CA, US
Cardiodynamics International Corp. appears in FDA device records in San Diego, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Cardiodynamics International Corp. between 1996 and 2009. The busiest year on record is 2000, with 2. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090602 | CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS | DSB | Substantially Equivalent | |
| K070156 | BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 | DSB | Substantially Equivalent | |
| K051228 | BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG | DSB | Substantially Equivalent | |
| K041294 | BIOZDX HEMODYNAMIC MONITOR | DSB | Substantially Equivalent | |
| K011439 | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR | DSB | Substantially Equivalent | |
| K011797 | BIOZTECT SENSOR AND BIOZTECT CABLE | DSB | Substantially Equivalent | |
| K001081 | BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 | DSB | Substantially Equivalent | |
| K001100 | BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH | DSB | Substantially Equivalent | |
| K974725 | BIOZ.COM SYSTEM | DSB | Substantially Equivalent | |
| K972320 | BIOZ SYSTEM & BIOZ PORTABLE | DSB | Substantially Equivalent | |
| K963183 | BIOZ SYSTEM | DSB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain