The following data is part of a premarket notification filed by Humed, Inc. with the FDA 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.
| Device ID | K971442 |
| 510k Number | K971442 |
| Device Name: | 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 |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | HUMED, INC. 709 N. MEMORIAL PKWY. Huntsville, AL 35801 |
| Contact | Charles B Hughes |
| Correspondent | Charles B Hughes HUMED, INC. 709 N. MEMORIAL PKWY. Huntsville, AL 35801 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1998-01-08 |
| Summary: | summary |