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 Oximeter
510(k) Number K874947
Device Name MODEL 8800 CARDIORESPIRATORY OXIMETER
Applicant
NONIN MEDICAL, INC.
13030 HIGHWAY 55
PLYMOUTH,  MA  55441
Applicant Contact NEAL F NORDLING
Correspondent
NONIN MEDICAL, INC.
13030 HIGHWAY 55
PLYMOUTH,  MA  55441
Correspondent Contact NEAL F NORDLING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/02/1987
Decision Date 02/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-