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510(k) K812720

BODAI PATIENT COMMUNICATOR by Sontek Industries, Inc. — Product Code ILQ

K812720 is an FDA 510(k) premarket notification submitted by Sontek Industries, Inc. for the device "BODAI PATIENT COMMUNICATOR". The FDA issued a decision of Substantially Equivalent on November 5, 1981. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. Sontek Industries, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1981
Date Received
September 25, 1981
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 Sontek Industries, Inc.

  • K833372 — BODIA TRACH-SAF DOUBLE SWIVEL (November 3, 1983)
  • K833373 — BODIA BRONCH-SAF DOUBLE SWIVEL (November 3, 1983)
  • K833361 — TUBE-TITLE (November 3, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K813324 — BODAI SWIVEL Y (December 29, 1981)
  • K811241 — BODAI SUCTION -SAFE 4 (May 27, 1981)

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)
  • K924014 — SECRETARY (March 4, 1993)
  • K924030 — SCRIBE (March 4, 1993)

FDA data resources