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 Transducer, Blood-Pressure, Extravascular
510(k) Number K061573
Device Name TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
Applicant
Hospira, Inc.
275 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact THOMAS KOZMA
Correspondent
Hospira, Inc.
275 N. Field Dr.
Lake Forest,  IL  60045
Correspondent Contact THOMAS KOZMA
Regulation Number870.2850
Classification Product Code
DRS  
Date Received06/07/2006
Decision Date 09/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-