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 gastroscope and accessories, flexible/rigid
510(k) Number K974493
Device Name FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES
Applicant
FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH
GAENSAECKER 42
TUTTLINGEN,  DE D-78532
Correspondent
FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH
GAENSAECKER 42
TUTTLINGEN,  DE D-78532
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Codes
FAM   FDF   FDT   FEM  
Date Received11/28/1997
Decision Date 03/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-