510(k) K781461

MODEL 7320 VISUAL STIMULATOR by Life-Tech Instruments, Inc. — Product Code GWE

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