The following data is part of a premarket notification filed by Sensory Aids Corp. with the FDA for Keynote.
Device ID | K863995 |
510k Number | K863995 |
Device Name: | KEYNOTE |
Classification | System, Communication, Powered |
Applicant | SENSORY AIDS CORP. 205 WEST GRAND AVENUE, SUITE 122 Bensenville, IL 60106 |
Contact | Ron B Merrick |
Correspondent | Ron B Merrick SENSORY AIDS CORP. 205 WEST GRAND AVENUE, SUITE 122 Bensenville, IL 60106 |
Product Code | ILQ |
CFR Regulation Number | 890.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-14 |
Decision Date | 1986-11-13 |