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 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K040969
Device Name POISE DATAENGINE
Applicant
POISE TECHNOLOGY CORPORATION
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
POISE TECHNOLOGY CORPORATION
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/14/2004
Decision Date 06/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-