Medical Device Manufacturer · US , San Diego , CA

Cardiodynamics International Corp. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1996

Recent clearances: CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS, BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100, BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG

View 11 510(k) Devices ↓

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiodynamics International Corp. Cardiovascular ✕

11 devices

1-11 of 11

Cleared May 28, 2009

CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS

Cardiovascular · 84d

Cleared Sep 26, 2007

BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100

Cardiovascular · 252d

Cleared Jun 10, 2005

BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG

Cardiovascular · 28d

Cleared Dec 08, 2004

BIOZDX HEMODYNAMIC MONITOR

Cardiovascular · 208d

Cleared Nov 02, 2001

MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR

Cardiovascular · 176d

Cleared Jul 03, 2001

BIOZTECT SENSOR AND BIOZTECT CABLE

Cardiovascular · 25d

Cleared Jun 30, 2000

BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501

Cardiovascular · 87d

Cleared May 05, 2000

BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE...

Cardiovascular · 30d

Cleared Mar 18, 1998

BIOZ.COM SYSTEM

Cardiovascular · 90d

Cleared Sep 11, 1997

BIOZ SYSTEM & BIOZ PORTABLE

Cardiovascular · 80d

Cleared Nov 26, 1996

Cardiovascular · 104d