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, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K091985
Device Name UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
Applicant
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Applicant Contact DICK LISTRO
Correspondent
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Correspondent Contact DICK LISTRO
Regulation Number870.2300
Classification Product Code
DRT  
Date Received07/02/2009
Decision Date 07/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-