Device Classification Name |
Adjunct Monitor, Protein Calorie Malnutrition
|
510(k) Number |
K190529 |
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 Number | 870.2770
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/04/2019 |
Decision Date | 11/25/2019 |
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
|
|
|