The following data is part of a premarket notification filed by Intellitech with the FDA for Dr. Dry.
Device ID | K895346 |
510k Number | K895346 |
Device Name: | DR. DRY |
Classification | Alarm, Conditioned Response Enuresis |
Applicant | INTELLITECH 5403 CANDLELIGHT DR. La Jolla, CA 92037 |
Contact | Mark Wiesner |
Correspondent | Mark Wiesner INTELLITECH 5403 CANDLELIGHT DR. La Jolla, CA 92037 |
Product Code | KPN |
CFR Regulation Number | 876.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-01 |
Decision Date | 1989-10-24 |