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 Electrocardiograph
510(k) Number K855096
Device Name SIEMENS SIRECUST MODELS 403P,403-2P & 403N
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 Number870.2340
Classification Product Code
DPS  
Date Received12/23/1985
Decision Date 07/15/1986
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
-
-