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 electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K994346
Device Name ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
Applicant
SENDX MEDICAL, INC.
1945 PALOMAR OAKS WAY
CARLSBAD,  CA  92011
Applicant Contact MARTIN SELLERS
Correspondent
SENDX MEDICAL, INC.
1945 PALOMAR OAKS WAY
CARLSBAD,  CA  92011
Correspondent Contact MARTIN SELLERS
Regulation Number862.1120
Classification Product Code
CHL  
Date Received12/23/1999
Decision Date 02/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-