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 Transducer, Ultrasonic
510(k) Number K905157
Device Name FLOSCOPE VASCULAR LAB.
Applicant
Advance Medical Device, Inc.
2733 Saunders St.
P.O. Box 1419
Camden,  NJ  08105
Applicant Contact DAVID LERNER
Correspondent
Advance Medical Device, Inc.
2733 Saunders St.
P.O. Box 1419
Camden,  NJ  08105
Correspondent Contact DAVID LERNER
Regulation Number870.2880
Classification Product Code
JOP  
Date Received11/16/1990
Decision Date 03/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-