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 K884455
Device Name MODEL 702 ECG/RESPIRATION/TEMPERATURE
Applicant
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Applicant Contact BRENDA E LUNDY
Correspondent
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Correspondent Contact BRENDA E LUNDY
Regulation Number870.2300
Classification Product Code
DRT  
Date Received10/24/1988
Decision Date 03/09/1989
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
-
-