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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
Subpart C—Monitoring Devices
CFR Sub-Part
KPN
Alarm, Conditioned Response Enuresis
2
Product Code
K
13
0951
SIM
2
Cleared 510(K)
K
97
1442
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5
2
Cleared 510(K)
K
97
1855
POTTY PAL AND FOREVER-DRY
2
Cleared 510(K)
K
96
2770
UROSURGE ACUTRAINER
2
Cleared 510(K)
K
96
2416
DRYTIME FOR BLADDER CONTROL SILENT
2
Cleared 510(K)
K
95
5338
DRYTIME FOR POTTY TRAINING
2
Cleared 510(K)
K
94
3559
REMOTE A'LERT
2
Cleared 510(K)
K
94
3558
PRO'TECT
2
Cleared 510(K)
K
94
2057
FISHER-PRICE DRY NIGHT MONITOR
2
Cleared 510(K)
K
93
5915
WET SENSE
2
Cleared 510(K)
Show All 37 Submissions
OQT
Prostate Lesion, Documentation, System
2
Product Code
QEF
Pressure Ulcer Management Tool
1
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
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Last synced on 9 May 2025 at 11:05 pm
GU
/
subpart-c—monitoring-devices
/
KPN
/
K943558
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PRO'TECT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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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
KPN
Alarm, Conditioned Response Enuresis
K
13
0951
SIM
K
97
1442
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5
K
97
1855
POTTY PAL AND FOREVER-DRY
K
96
2770
UROSURGE ACUTRAINER
K
96
2416
DRYTIME FOR BLADDER CONTROL SILENT
K
95
5338
DRYTIME FOR POTTY TRAINING
K
94
3559
REMOTE A'LERT
K
94
3558
PRO'TECT
K
94
2057
FISHER-PRICE DRY NIGHT MONITOR
K
93
5915
WET SENSE
Show All 37 Submissions
OQT
Prostate Lesion, Documentation, System
QEF
Pressure Ulcer Management Tool
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—monitoring-devices
/
KPN
/
K943558
View Source
PRO'TECT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...