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 Plethysmograph, Impedance
510(k) Number K172507
Device Name SOZO
Applicant
ImpediMed Limited
Unit 1
50 Parker Court
Pinkenba,  AU 4008
Applicant Contact Catherine Kingsford
Correspondent
ImpediMed Inc.
5900 Pasteur Court, Unit 125
Carlsbad,  CA  92008
Correspondent Contact Reuben Lawson
Regulation Number870.2770
Classification Product Code
DSB  
Date Received08/18/2017
Decision Date 12/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-