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 K852790
Device Name ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT
Applicant
NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM,  MA  02454 -9141
Applicant Contact PAUL W MACDONALD
Correspondent
NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM,  MA  02454 -9141
Correspondent Contact PAUL W MACDONALD
Regulation Number862.1120
Classification Product Code
CHL  
Date Received07/01/1985
Decision Date 11/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-