510(k) K863995
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