• 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 transmitters and receivers, electrocardiograph, telephone
510(k) Number K002004
Device Name ZYBIT
Applicant
ZYMED MEDICAL INSTRUMENTATION
1201 B NORTH RICE AVE.
OXNARD,  CA  93030
Applicant Contact GRETEL LUMLEY
Correspondent
ZYMED MEDICAL INSTRUMENTATION
1201 B NORTH RICE AVE.
OXNARD,  CA  93030
Correspondent Contact GRETEL LUMLEY
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/03/2000
Decision Date 09/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-