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510(k) K812720

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

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.

  • K833373 — BODIA BRONCH-SAF DOUBLE SWIVEL (November 3, 1983)
  • K833372 — BODIA TRACH-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)

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