• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name ventilator, continuous, facility use
510(k) Number K010925
Device Name SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
Original Applicant
SIEMENS ELEMA AB
medical solutions
186 wood avenue south
iselin,  NJ  08830 -2770
Original Contact diane wurzburger
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/27/2001
Decision Date 12/18/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-