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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K033030
Device Name CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
Applicant
Witt Biomedical Corp
305 N. Dr.
Melbourne,  FL  32934
Applicant Contact ELFRIEDE PAGAN
Correspondent
Witt Biomedical Corp
305 N. Dr.
Melbourne,  FL  32934
Correspondent Contact ELFRIEDE PAGAN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/26/2003
Decision Date 02/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-