Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- KPNAlarm, Conditioned Response Enuresis2Product Code
- K130951SIM2Cleared 510(K)
- K971442HUGHES 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-52Cleared 510(K)
- K971855POTTY PAL AND FOREVER-DRY2Cleared 510(K)
- K962770UROSURGE ACUTRAINER2Cleared 510(K)
- K962416DRYTIME FOR BLADDER CONTROL SILENT2Cleared 510(K)
- K955338DRYTIME FOR POTTY TRAINING2Cleared 510(K)
- K943559REMOTE A'LERT2Cleared 510(K)
- K943558PRO'TECT2Cleared 510(K)
- K942057FISHER-PRICE DRY NIGHT MONITOR2Cleared 510(K)
- K935915WET SENSE2Cleared 510(K)
Show All 37 Submissions
- OQTProstate Lesion, Documentation, System2Product Code
- QEFPressure Ulcer Management Tool1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
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- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
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- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PRO'TECT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K943558
- 510(k) Type
- Traditional
- Applicant
- HEALTH SENSE INTL., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/24/1995
- Days to Decision
- 306 days
- Submission Type
- Summary