510(k) K101691
K101691 is an FDA 510(k) premarket notification submitted by Lifelines , Ltd. for the device "LIFELINES PHOTIC STIMULATOR". The FDA issued a decision of Substantially Equivalent on August 10, 2010. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Lifelines , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2010
- Date Received
- June 16, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Photic, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1890
- Review Panel
- NE
- Submission Type