• 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 K181695
Device Name Nihon Kohden NKV-550 Series Ventilator System
Applicant
Nihon Kohden OrangeMed, Inc.
1800 E. Wilshire Ave.
Santa Ana,  CA  92705
Applicant Contact Sheryl Higgins
Correspondent
Nihon Kohden OrangeMed, Inc.
1800 E. Wilshire Ave.
Santa Ana,  CA  92705
Correspondent Contact Sheryl Higgins
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/27/2018
Decision Date 12/07/2018
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
-
-