510(k) K043491
K043491 is an FDA 510(k) premarket notification submitted by Diopsys, Inc. for the device "ENFANTTM". The FDA issued a decision of Substantially Equivalent on March 16, 2005. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Diopsys, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2005
- Date Received
- December 17, 2004
- 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