• 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 Interventional Fluoroscopic X-Ray System
510(k) Number K101833
Device Name INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
Applicant
INFIMED, INC.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
INFIMED, INC.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   MQB  
Date Received07/01/2010
Decision Date 07/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-