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 K100020
Device Name DX SERIES FINGER SENSOR
Applicant
DIXTAL MEDICAL INC.
101 N. Plains Industrial Rd.
Building No. 2
Wallingford,  CT  06492 -0000
Applicant Contact ROBERT SCHIFFMAN
Correspondent
DIXTAL MEDICAL INC.
101 N. Plains Industrial Rd.
Building No. 2
Wallingford,  CT  06492 -0000
Correspondent Contact ROBERT SCHIFFMAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/05/2010
Decision Date 03/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-