The following data is part of a premarket notification filed by Lifelines Ltd. with the FDA for Lifelines Photic Stimulator.
| Device ID | K101691 |
| 510k Number | K101691 |
| Device Name: | LIFELINES PHOTIC STIMULATOR |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | LIFELINES LTD. 1468 Harwell Avenue Crofton, MD 21114 |
| Contact | E. J Amith |
| Correspondent | E. J Amith LIFELINES LTD. 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-16 |
| Decision Date | 2010-08-10 |
| Summary: | summary |