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 Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K860693
Device Name PULMANEX (TM)
Applicant
Life Design Systems, Inc.
11017 W. Layton Ave.
Milwaukee,  WI  53228
Applicant Contact GILBERT M KIRK
Correspondent
Life Design Systems, Inc.
11017 W. Layton Ave.
Milwaukee,  WI  53228
Correspondent Contact GILBERT M KIRK
Regulation Number868.5915
Classification Product Code
BTM  
Date Received02/25/1986
Decision Date 03/27/1986
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
-
-