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 K260224
Device Name MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
Applicant
ImpediMed Limited
Suite 31c
12-18 Tryon Rd.
Lindfield,  AU 2070
Applicant Contact Richard Hines
Correspondent
ImpediMed Limited
Suite 31c
12-18 Tryon Rd.
Lindfield,  AU 2070
Correspondent Contact Richard Hines
Regulation Number870.2770
Classification Product Code
DSB  
Subsequent Product Codes
MNW   QJB  
Date Received01/26/2026
Decision Date 08/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-