FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOZ SYSTEM
K Number: K963183
·
Decision Nov 26, 1996
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
11
Review Days
104
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Basic Information
- Device Name
- BIOZ SYSTEM
- K Number
- K963183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardiodynamics International Corp.
- Date Received
- August 14, 1996
- Decision Date
- November 26, 1996
- Product Code
- DSB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiodynamics International Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K090602 | CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS | May 28, 2009 | Substantially Equivalent |
| K070156 | BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 | Sep 26, 2007 | Substantially Equivalent |
| K051228 | BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG | Jun 10, 2005 | Substantially Equivalent |
| K041294 | BIOZDX HEMODYNAMIC MONITOR | Dec 8, 2004 | Substantially Equivalent |
| K011439 | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR | Nov 2, 2001 | Substantially Equivalent |
| K011797 | BIOZTECT SENSOR AND BIOZTECT CABLE | Jul 3, 2001 | Substantially Equivalent |
| K001081 | BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 | Jun 30, 2000 | Substantially Equivalent |
| K001100 | BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH | May 5, 2000 | Substantially Equivalent |
| K974725 | BIOZ.COM SYSTEM | Mar 18, 1998 | Substantially Equivalent |
| K972320 | BIOZ SYSTEM & BIOZ PORTABLE | Sep 11, 1997 | Substantially Equivalent |