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 meter, conductivity, non-remote
510(k) Number K201765
Device Name SmartHDM-510 System
Applicant
Mesa Laboratories, Inc.
12100 West 6th Ave.
Lakewood,  CO  80228
Applicant Contact Jamie Louie
Correspondent
IBP Medical GmbH
Ikarusallee 15
Hannover,  DE 30179
Correspondent Contact Johannes Pfingstmann
Regulation Number876.5820
Classification Product Code
FIZ  
Date Received06/29/2020
Decision Date 09/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-