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 Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
510(k) Number K970906
Device Name PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR
Applicant
Diametrics Medical, Ltd.
Short St.
High Wycombe, Buckinghamshire,  GB HP11 2QH
Applicant Contact JAN WALTERS
Correspondent
Diametrics Medical, Ltd.
Short St.
High Wycombe, Buckinghamshire,  GB HP11 2QH
Correspondent Contact JAN WALTERS
Regulation Number868.1170
Classification Product Code
CBZ  
Subsequent Product Codes
CCC   CCE  
Date Received03/12/1997
Decision Date 09/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-