Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Plethysmograph, Impedance
510(k) Number K001081
Device Name BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
Applicant
CARDIODYNAMICS INTERNATIONAL CORP.
6175 NANCY RIDGE DR., #300
SAN DIEGO,  CA  92121
Applicant Contact BRIAN PARK
Correspondent
CARDIODYNAMICS INTERNATIONAL CORP.
6175 NANCY RIDGE DR., #300
SAN DIEGO,  CA  92121
Correspondent Contact BRIAN PARK
Regulation Number870.2770
Classification Product Code
DSB  
Date Received04/04/2000
Decision Date 06/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-