The following data is part of a premarket notification filed by Bio-systems Research with the FDA for Drytime For Bladder Control Silent.
| Device ID | K962416 |
| 510k Number | K962416 |
| Device Name: | DRYTIME FOR BLADDER CONTROL SILENT |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | BIO-SYSTEMS RESEARCH 2057 SUMMIT DR. Lake Oswego, OR 97034 |
| Contact | Arthur J Saffir |
| Correspondent | Arthur J Saffir BIO-SYSTEMS RESEARCH 2057 SUMMIT DR. Lake Oswego, OR 97034 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-30 |
| Decision Date | 1996-07-22 |
| Summary: | summary |