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 Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K101487
Device Name CHEETAH NICOM SYSTEM
Applicant
Cheetah Medical, Inc.
12154 Darnestown Rd., #236
Gaithersburg,  MD  20878
Applicant Contact Rhona Shanker
Correspondent
Cheetah Medical, Inc.
12154 Darnestown Rd., #236
Gaithersburg,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number870.1435
Classification Product Code
DXG  
Date Received05/28/2010
Decision Date 07/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-