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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
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Subpart C—Cardiovascular Monitoring Devices
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Subpart C—Monitoring Devices
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Subpart F—Therapeutic Devices
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Subpart G—General Hospital and Personal Use Miscellaneous Devices
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OZW
Ingestible Event Marker
2
Product Code
K
25
1088
Otsuka Digital Feedback Device
2
Cleared 510(K)
K
22
3463
Otsuka Digital Feedback Device-RW
2
Cleared 510(K)
K
18
3052
ID-Cap System
2
Cleared 510(K)
K
15
0494
Proteus Digital Health Feedback Device
2
Cleared 510(K)
K
13
3263
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
2
Cleared 510(K)
K
13
1524
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
2
Cleared 510(K)
K
13
1009
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
2
Cleared 510(K)
DEN
12
0011
PROTEUS INGESTION CONFINMATION SYSTEMS
2
Cleared 510(K)
General Hospital
Review Panel
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Neurology
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Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
GU
/
subpart-g—general-hospital-and-personal-use-miscellaneous-devices
/
OZW
/
K133263
View Source
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
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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
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
OZW
Ingestible Event Marker
K
25
1088
Otsuka Digital Feedback Device
K
22
3463
Otsuka Digital Feedback Device-RW
K
18
3052
ID-Cap System
K
15
0494
Proteus Digital Health Feedback Device
K
13
3263
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
K
13
1524
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
K
13
1009
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
DEN
12
0011
PROTEUS INGESTION CONFINMATION SYSTEMS
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-g—general-hospital-and-personal-use-miscellaneous-devices
/
OZW
/
K133263
View Source
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...