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 airway, oropharyngeal, anesthesiology
510(k) Number K950613
Device Name KEISEI
Applicant
KEISEI (USA) CO., LTD.
23717 HAWTHORNE BLVD., #305
TORRANCE,  CA  90505
Applicant Contact YUJI FUNAI
Correspondent
KEISEI (USA) CO., LTD.
23717 HAWTHORNE BLVD., #305
TORRANCE,  CA  90505
Correspondent Contact YUJI FUNAI
Regulation Number868.5110
Classification Product Code
CAE  
Date Received02/10/1995
Decision Date 02/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-