LIFELINES PHOTIC STIMULATOR
FDA 510(k) clearance K101691 · decided 2010-08-10
Clearance details
- K-number
- K101691
- Device name
- LIFELINES PHOTIC STIMULATOR
- Applicant
- Lifelines , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-16
- Decision date
- 2010-08-10
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- GWE
- Device class
- 2
- Regulation number
- 882.1890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.