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510(k) K901029

YES-NO VOICE BOX 7011 by Baylor Biomedical Services — Product Code ILQ

K901029 is an FDA 510(k) premarket notification submitted by Baylor Biomedical Services for the device "YES-NO VOICE BOX 7011". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. Baylor Biomedical Services has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
March 6, 1990
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

Other clearances by Baylor Biomedical Services

  • K900969 — REMOTE CONTROL SWITCH (March 13, 1990)
  • K901030 — ROTARY COMMUNICATION SCANNER MODEL 7010 (March 13, 1990)
  • K901028 — ENVIRONMENTAL CONTROL UNIT MODEL 7000 (March 13, 1990)

Other clearances for product code ILQ

  • K162817 — Noddle(TM) (January 18, 2017)
  • K943035 — P.A.T. SYSTEM (October 4, 1994)
  • K930044 — COMFORT KEYBOARD SYSTEM (July 14, 1994)
  • K931855 — LIGHTWRITER (May 10, 1994)
  • K935244 — R & D BATTERIES, INC. PART NUMBER 5113 (April 19, 1994)
  • K935981 — MLT-2 (February 17, 1994)
  • K925387 — LIBERATOR (March 29, 1993)
  • K925527 — LIGHT TALKER (March 22, 1993)
  • K924030 — SCRIBE (March 4, 1993)
  • K924014 — SECRETARY (March 4, 1993)

FDA data resources