The following data is part of a premarket notification filed by Fisher Price with the FDA for Fisher-price Dry Night Monitor.
| Device ID | K942057 |
| 510k Number | K942057 |
| Device Name: | FISHER-PRICE DRY NIGHT MONITOR |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | FISHER PRICE 636 GIRARD AVE. East Aurora, NY 14052 |
| Contact | Gary Jones |
| Correspondent | Gary Jones FISHER PRICE 636 GIRARD AVE. East Aurora, NY 14052 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-28 |
| Decision Date | 1994-07-28 |