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 Uroflowmeter
510(k) Number K945495
Device Name 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
Applicant
Fiberoptic Sensor Technlogies, Inc.
501 Avis Dr.
Ann Arbor,  MI  48108
Applicant Contact GARY C SIMPSON
Correspondent
Fiberoptic Sensor Technlogies, Inc.
501 Avis Dr.
Ann Arbor,  MI  48108
Correspondent Contact GARY C SIMPSON
Regulation Number876.1800
Classification Product Code
EXY  
Date Received11/08/1994
Decision Date 02/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-