The following data is part of a premarket notification filed by Digital Applications, Inc. with the FDA for Potty Pal And Forever-dry.
Device ID | K971855 |
510k Number | K971855 |
Device Name: | POTTY PAL AND FOREVER-DRY |
Classification | Alarm, Conditioned Response Enuresis |
Applicant | DIGITAL APPLICATIONS, INC. 275 E. 300 S Santaquin, UT 84655 |
Contact | D. Lynn Sheppard |
Correspondent | D. Lynn Sheppard DIGITAL APPLICATIONS, INC. 275 E. 300 S Santaquin, UT 84655 |
Product Code | KPN |
CFR Regulation Number | 876.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-20 |
Decision Date | 1997-08-18 |
Summary: | summary |