• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K970839
Device Name SERVO VENTILATOR 300A
Original Applicant
SIEMENS ELEMA AB
rontgenvagen 2
s-17195 solna,  SW
Original Contact ann-christine jonsson
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/07/1997
Decision Date 10/14/1997
Decision se subject to tracking reg (ST)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-