• 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 Electrocardiograph
510(k) Number K904606
Device Name MODEL 405
Applicant
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Applicant Contact M SIMON
Correspondent
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Correspondent Contact M SIMON
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/10/1990
Decision Date 03/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-