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 K133859
Device Name WATCH-PAT200U (WP200U)
Applicant
Itamar Medical , Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN KAHAN, ESQ
Correspondent
Itamar Medical , Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN KAHAN, ESQ
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/19/2013
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT00881829
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-