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 K130740
Device Name NIGHTINGALE MONITORING SYSTEM
Applicant
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Applicant Contact JAMES CHICKERING
Correspondent
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Correspondent Contact JAMES CHICKERING
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/19/2013
Decision Date 07/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-