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 Bronchoscope (Flexible Or Rigid)
510(k) Number K131028
Device Name PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
Applicant
PENTAX MEDICAL COMPANY
3 PARAGON DRIVE
MONTVALE,  NJ  07645
Applicant Contact KRISHNA GOVINDARAJAN
Correspondent
PENTAX MEDICAL COMPANY
3 PARAGON DRIVE
MONTVALE,  NJ  07645
Correspondent Contact KRISHNA GOVINDARAJAN
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/12/2013
Decision Date 04/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-