• 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 monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K013311
Device Name MODIFICATION TO: POCKETVIEW ECG SOFTWARE
Applicant
MICROMEDICAL INDUSTRIES, LTD.
11 TECHNOLOGY DR.
labrador queensland,  AU 4215
Applicant Contact stephen cresswell
Correspondent
MICROMEDICAL INDUSTRIES, LTD.
11 TECHNOLOGY DR.
labrador queensland,  AU 4215
Correspondent Contact stephen cresswell
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/04/2001
Decision Date 01/03/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-