The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Dritrainer.
| Device ID | K930005 |
| 510k Number | K930005 |
| Device Name: | DRITRAINER |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | Mary M Mcnamara |
| Correspondent | Mary M Mcnamara LABORIE MEDICAL TECHNOLOGIES, LTD. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-04 |
| Decision Date | 1993-03-03 |