The following data is part of a premarket notification filed by Sleep Performance D.b.a. Fatigue Science with the FDA for Sbv2, Multicharger Model Mc10v2.
| Device ID | K111514 |
| 510k Number | K111514 |
| Device Name: | SBV2, MULTICHARGER MODEL MC10V2 |
| Classification | Device, Sleep Assessment |
| Applicant | SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE 5405 ALTON PARKWAY SUITE A530 Irvine, CA 92604 |
| Contact | Marc Goodman |
| Correspondent | Marc Goodman SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE 5405 ALTON PARKWAY SUITE A530 Irvine, CA 92604 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-01 |
| Decision Date | 2011-12-16 |
| Summary: | summary |