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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
MNW
Analyzer, Body Composition
2
Product Code
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
2
Product Code
OMV
Ultrasonic Body Composition Analyzer
2
Product Code
PUH
Analyzer, Body Composition, Exempt
2
Product Code
QJB
Adjunct Monitor, Protein Calorie Malnutrition
2
Product Code
K
23
0531
SOZO Pro
2
Cleared 510(K)
K
19
0529
SOZO
2
Cleared 510(K)
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
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Subpart E—Surgical Devices
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Subpart F—Neurological Therapeutic Devices
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Unknown
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Last synced on 16 August 2024 at 11:05 pm
GU
/
subpart-c—cardiovascular-monitoring-devices
/
QJB
/
K230531
View Source
SOZO Pro
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230531
510(k) Type
Special
Applicant
ImpediMed Limited
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
5/4/2023
Days to Decision
66 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
MNW
Analyzer, Body Composition
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
OMV
Ultrasonic Body Composition Analyzer
PUH
Analyzer, Body Composition, Exempt
QJB
Adjunct Monitor, Protein Calorie Malnutrition
K
23
0531
SOZO Pro
K
19
0529
SOZO
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-c—cardiovascular-monitoring-devices
/
QJB
/
K230531
View Source
SOZO Pro
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230531
510(k) Type
Special
Applicant
ImpediMed Limited
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
5/4/2023
Days to Decision
66 days
Submission Type
Summary