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 Ventilatory Effort Recorder
510(k) Number K080427
Device Name WATCH-PAT MODEL 100S-2
Applicant
ITAMAR MEDICAL
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
ITAMAR MEDICAL
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/15/2008
Decision Date 05/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-