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 K972833
Device Name E100M VENTILATOR (E100M)
Applicant
Newport Medical Instruments, Inc.
760 W. 16th St., Bldg. M
Costa Mesa,  CA  92627
Applicant Contact KARON MORELL
Correspondent
Newport Medical Instruments, Inc.
760 W. 16th St., Bldg. M
Costa Mesa,  CA  92627
Correspondent Contact KARON MORELL
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/30/1997
Decision Date 09/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-