Device Classification Name |
plethysmograph, impedance
|
510(k) Number |
K232089 |
Device Name |
SOZO Pro |
Applicant |
ImpediMed Limited |
Unit 1 |
50 Parker Court |
Pinkenba,
AU
4008
|
|
Applicant Contact |
Dennis Schlaht |
Correspondent |
ImediMed Inc. |
5900 Pasteur Court, Unit 125 |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Richard Hines |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 07/13/2023 |
Decision Date | 10/17/2023 |
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
|
|
|