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, Continuous, Facility Use
510(k) Number K032226
Device Name LTV-1000 VENTILATOR
Applicant
PULMONETIC SYSTEMS, INC.
17400 MEDINA RD.
SUITE 100
MINNEAPOLIS,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
PULMONETIC SYSTEMS, INC.
17400 MEDINA RD.
SUITE 100
MINNEAPOLIS,  MN  55447
Correspondent Contact ROBERT C SAMEC
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/21/2003
Decision Date 10/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-