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(With Arrhythmia Detection Or Alarms)
510(k) Number K030931
Device Name C3 PATIENT MONITOR
Applicant
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact MARVIN ROSENBAUM
Correspondent
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact MARVIN ROSENBAUM
Regulation Number870.1025
Classification Product Code
MHX  
Date Received03/25/2003
Decision Date 05/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-