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— 510(k) K971442
Substantially EquivalentHumed, Inc.
FDA 510(k) clearance K971442 for 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, Substantially Equivalent on 1998-01-08. Applicant: Humed, Inc.. Device class: 2.
Clearance details
- Applicant
- Humed, Inc.
- Product code
- Code KPN
- Device class
- Class 2
- Regulation
- 21 CFR 876.2040
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntsville, AL, US
Recent devices under product code KPN
view allData sourced from openFDA. This site is unofficial and independent of the FDA.