• 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, external body, negative pressure, adult (cuirass)
510(k) Number K840885
Device Name LAKEVILLE BODY VENTILATOR
Applicant
EDWARDS VENTILATOR CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EDWARDS VENTILATOR CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5935
Classification Product Code
BYT  
Date Received02/27/1984
Decision Date 07/12/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-