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, Programmable
510(k) Number K914577
Device Name RHYTHMSCAN PRECISION 6000
Applicant
Precision Health Care Systems, Inc.
3541 Lomita Blvd.
Torrance,  CA  90505
Applicant Contact MAHA SADRAS
Correspondent
Precision Health Care Systems, Inc.
3541 Lomita Blvd.
Torrance,  CA  90505
Correspondent Contact MAHA SADRAS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/15/1991
Decision Date 05/08/1992
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
-
-