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 monitor, breathing frequency
510(k) Number K070375
Device Name EARLYSENSE ES-16 SYSTEM
Applicant
EARLYSENSE LTD.
7, JABOTINSKY ST.
RAMAT GAN,  IL 52520
Applicant Contact DORIT WINITZ
Correspondent
EARLYSENSE LTD.
7, JABOTINSKY ST.
RAMAT GAN,  IL 52520
Correspondent Contact DORIT WINITZ
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received02/08/2007
Decision Date 11/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-