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 K840523
Device Name SERVOMED PULSE AMPLIFIER MODULE-206-
Applicant
Litton Medical Electronics
777 Nicholas Blvd.
Elk Grove Village,  IL  60007
Applicant Contact CASARSA
Correspondent
Litton Medical Electronics
777 Nicholas Blvd.
Elk Grove Village,  IL  60007
Correspondent Contact CASARSA
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/07/1984
Decision Date 10/29/1984
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
-
-