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Subpart B—Diagnostic Devices
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Subpart B—Obstetrical and Gynecological Diagnostic Devices
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Subpart C—Cardiovascular Monitoring Devices
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MNW
Analyzer, Body Composition
2
Product Code
K
23
1116
Multi-parameter detector
2
Cleared 510(K)
K
14
0045
BODY COMPOSITION ANALYZER
2
Cleared 510(K)
K
14
1483
BIOSPACE BODY COMPOSITION ANALYZER
2
Cleared 510(K)
K
13
3872
ARIA WIFI SMART SCALE
2
Cleared 510(K)
K
14
0594
BODY FAT ANALYZER AND SCALE
2
Cleared 510(K)
K
13
0856
BIA / VITALITY ANALYZER
2
Cleared 510(K)
K
13
0777
INBODY
2
Cleared 510(K)
K
13
0952
PRECISION ONE LIFECARE; DETECTO; DETECTO
2
Cleared 510(K)
K
13
1394
TRANSTEK GLASS BODY FAT ANALYZER
2
Cleared 510(K)
K
13
0311
TRANSTEK BODY FAT ANALYZER
2
Cleared 510(K)
Show All 79 Submissions
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
Subpart C—Monitoring Devices
CFR Sub-Part
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Subpart F—Physical Medicine Therapeutic Devices
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Subpart F—Therapeutic Devices
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Last synced on 30 November 2024 at 11:09 am
GU
/
subpart-c—cardiovascular-monitoring-devices
/
MNW
/
K133872
View Source
ARIA WIFI SMART SCALE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133872
510(k) Type
Traditional
Applicant
FITBIT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/2/2014
Days to Decision
164 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
K
23
1116
Multi-parameter detector
K
14
0045
BODY COMPOSITION ANALYZER
K
14
1483
BIOSPACE BODY COMPOSITION ANALYZER
K
13
3872
ARIA WIFI SMART SCALE
K
14
0594
BODY FAT ANALYZER AND SCALE
K
13
0856
BIA / VITALITY ANALYZER
K
13
0777
INBODY
K
13
0952
PRECISION ONE LIFECARE; DETECTO; DETECTO
K
13
1394
TRANSTEK GLASS BODY FAT ANALYZER
K
13
0311
TRANSTEK BODY FAT ANALYZER
Show All 79 Submissions
OBH
Monitor, Extracellular Fluid, Lymphedema, Extremity
OMV
Ultrasonic Body Composition Analyzer
PUH
Analyzer, Body Composition, Exempt
QJB
Adjunct Monitor, Protein Calorie Malnutrition
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
/
MNW
/
K133872
View Source
ARIA WIFI SMART SCALE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133872
510(k) Type
Traditional
Applicant
FITBIT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/2/2014
Days to Decision
164 days
Submission Type
Summary