The following data is part of a premarket notification filed by Health Sense Intl., Inc. with the FDA for Drytime For Potty Training.
| Device ID | K955338 |
| 510k Number | K955338 |
| Device Name: | DRYTIME FOR POTTY TRAINING |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | HEALTH SENSE INTL., INC. 2057 SUMMIT DR. Lake Oswego, OR 97034 |
| Contact | Arthur J Saffir |
| Correspondent | Arthur J Saffir HEALTH SENSE INTL., INC. 2057 SUMMIT DR. Lake Oswego, OR 97034 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-03-12 |