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 |