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(with arrhythmia detection or alarms)
510(k) Number K173765
Device Name Surveyor Patient Monitor
Applicant
Mortara Instrument, Inc.
7865 North 86th Street
milwaukee,  WI  53224
Applicant Contact manisha gokuli
Correspondent
Mortara Instrument, Inc.
7865 North 86th Street
milwaukee,  WI  53224
Correspondent Contact manisha gokuli
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DPS   DQA   DSB   DSI   DSJ  
MLD   MSX  
Date Received12/11/2017
Decision Date 09/04/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-