K955338 is an FDA 510(k) clearance for the DRYTIME FOR POTTY TRAINING, a Alarm, Conditioned Response Enuresis (Class II — Special Controls, product code KPN), submitted by Health Sense Intl., Inc. (Lake Oswego, US). The FDA issued a Cleared decision on March 12, 1996, 112 days after receiving the submission on November 21, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.2040.
| 510(k) Number | K955338 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 1995 |
| Decision Date | March 12, 1996 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPN — Alarm, Conditioned Response Enuresis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.2040 |