510(k) K863995

KEYNOTE by Sensory Aids Corp. — Product Code ILQ

K863995 is an FDA 510(k) premarket notification submitted by Sensory Aids Corp. for the device "KEYNOTE". The FDA issued a decision of Substantially Equivalent on November 13, 1986. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. Sensory Aids Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1986
Date Received
October 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Powered
Device Class
Class II
Regulation Number
890.3710
Review Panel
PM
Submission Type