KEYNOTE— 510(k) K863995

Name: FDA 510(k) clearance K863995
Creator: U.S. Food and Drug Administration
Published: 1986-11-13

Substantially Equivalent

Sensory Aids Corp.

FDA 510(k) clearance K863995 for KEYNOTE, Substantially Equivalent on 1986-11-13. Applicant: Sensory Aids Corp.. Device class: 2.

Clearance details

Applicant: Sensory Aids Corp.
Product code: Code ILQ
Device class: Class 2
Regulation: 21 CFR 890.3710
Advisory panel: Physical Medicine
Date received: 1986-10-14
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bensenville, IL, US

Download summary PDF View on FDA.gov ↗

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K935244 — R & D BATTERIES, INC. PART NUMBER 51131994-04-19

More clearances from Sensory Aids Corp.

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K872042 — PLAYTONE AUDIOMETER1987-08-11
K863993 — VTS REPORTER OR VTS LINK1986-10-31
K863994 — VIEWSCAN1986-10-31

Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.