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 Tube, Tracheal (W/Wo Connector)
510(k) Number K945745
Device Name ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)
Applicant
Wolfe Tory Medical, Inc.
4425 S. 500 W.,Suite F
Salt Lake City,  UT  84123
Applicant Contact TIM WOLFE
Correspondent
Wolfe Tory Medical, Inc.
4425 S. 500 W.,Suite F
Salt Lake City,  UT  84123
Correspondent Contact TIM WOLFE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received11/23/1994
Decision Date 12/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-