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 K910281
Device Name INTRAVASCULAR IMAGING SYSTEM/MODIFIED
Applicant
Intertherapy, Inc.
1936 E. Deere Ave., Suite 120
Santa Ana,  CA  92705
Applicant Contact THOMAS P SCHROEDER
Correspondent
Intertherapy, Inc.
1936 E. Deere Ave., Suite 120
Santa Ana,  CA  92705
Correspondent Contact THOMAS P SCHROEDER
Regulation Number870.2880
Classification Product Code
JOP  
Date Received01/23/1991
Decision Date 05/13/1991
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
-
-