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 K970839
Device Name SERVO VENTILATOR 300A
Applicant
SIEMENS ELEMA AB
RONTGENVAGEN 2
S-17195 SOLNA,  SE
Applicant Contact ANN-CHRISTINE JONSSON
Correspondent
SIEMENS ELEMA AB
RONTGENVAGEN 2
S-17195 SOLNA,  SE
Correspondent 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)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-