510(k) K781461
K781461 is an FDA 510(k) premarket notification submitted by Life-Tech Instruments, Inc. for the device "MODEL 7320 VISUAL STIMULATOR". The FDA issued a decision of Substantially Equivalent on November 8, 1978. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Life-Tech Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1978
- Date Received
- August 18, 1978
- 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