The following data is part of a premarket notification filed by Health Sense Intl., Inc. with the FDA for Pro'tect.
| Device ID | K943558 |
| 510k Number | K943558 |
| Device Name: | PRO'TECT |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | HEALTH SENSE INTL., INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein HEALTH SENSE INTL., INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1995-05-24 |