• 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 K001775
Device Name ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
Applicant
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Applicant Contact PAUL M FITZMEYER
Correspondent
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Correspondent Contact PAUL M FITZMEYER
Regulation Number870.2300
Classification Product Code
DRT  
Date Received06/12/2000
Decision Date 01/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-