The following data is part of a premarket notification filed by Zygo Industries, Inc. with the FDA for Epison, Alerting System For Epileptics.
| Device ID | K862766 |
| 510k Number | K862766 |
| Device Name: | EPISON, ALERTING SYSTEM FOR EPILEPTICS |
| Classification | Device, Sleep Assessment |
| Applicant | ZYGO INDUSTRIES, INC. P.O. BOX 1008 Portland, OR 97207 -1008 |
| Contact | Lawrence H Weiss |
| Correspondent | Lawrence H Weiss ZYGO INDUSTRIES, INC. P.O. BOX 1008 Portland, OR 97207 -1008 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-22 |
| Decision Date | 1987-03-13 |