SBV2, MULTICHARGER MODEL MC10V2
FDA 510(k) clearance K111514 · decided 2011-12-16
Clearance details
- K-number
- K111514
- Device name
- SBV2, MULTICHARGER MODEL MC10V2
- Applicant
- Sleep Performance D.B.A. Fatigue Science
- Decision
- Substantially Equivalent
- Date received
- 2011-06-01
- Decision date
- 2011-12-16
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- LEL
- Device class
- 2
- Regulation number
- 882.5050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| EmbraceMini (K252981) | Empatica S.r.l. | 2025-12-22 |
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| ActiGraph LEAP activity monitor (ActiGraph LEAP) (K231532) | Actigraph, LLC | 2023-06-23 |
| ActiGraph CentrePoint Insight Watch (K181077) | Actigraph | 2018-05-24 |
| ActTrust (K151784) | Condor Instruments Ltda. - Epp | 2016-05-25 |
| MOTION WATCH AND PRO-DIARY (K132764) | Camntech, Ltd. | 2014-01-21 |
| CADWELL LIMB MOVEMENT MODULE (K040986) | Cadwell Laboratories, Inc. | 2004-07-01 |
| EASYNET BODY POSITION MODULE (K040932) | Cadwell Laboratories, Inc. | 2004-07-01 |
| REMVIEW SLEEP RECORDER, MODEL 320 (K003499) | Respironics, Inc. | 2001-02-09 |
Recalls involving this device
No recalls on record reference this clearance.