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 Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K983920
Device Name EMS PEEP VALVES- ADJUSTABLE
Applicant
Engineered Medical Systems
8529 Zionsville Rd.
P.O. Box 681514
Indianapolis,  IN  46268
Applicant Contact JEFF QUINN
Correspondent
Engineered Medical Systems
8529 Zionsville Rd.
P.O. Box 681514
Indianapolis,  IN  46268
Correspondent Contact JEFF QUINN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received11/04/1998
Decision Date 01/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-