• 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 K091238
Device Name UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
Applicant
IMPACT INSTRUMENTATION, INC.
27 FAIRFIELD PL.
WEST CALDWELL,  NJ  07006 -0508
Applicant Contact LESLIE H SHERMAN
Correspondent
IMPACT INSTRUMENTATION, INC.
27 FAIRFIELD PL.
WEST CALDWELL,  NJ  07006 -0508
Correspondent Contact LESLIE H SHERMAN
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
DQA  
Date Received04/27/2009
Decision Date 08/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-