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510(k) K911101

TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM by Zofcom, Inc. — Product Code IQA

K911101 is an FDA 510(k) premarket notification submitted by Zofcom, Inc. for the device "TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 25, 1991. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1991
Date Received
March 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Environmental Control, Powered
Device Class
Class II
Regulation Number
890.3725
Review Panel
PM
Submission Type

Other clearances for product code IQA

  • K961306 — DELTATALKER WITH INFRARED (June 27, 1996)
  • K953905 — IMPERIUM (November 21, 1995)
  • K953937 — LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM (October 31, 1995)
  • K943244 — DEUCE (September 11, 1995)
  • K944585 — SCANNING DIRECTOR (February 21, 1995)
  • K944345 — BEDSIDE BUTLER (October 17, 1994)
  • K940223 — LEARN MODE WATERPROOF PENDANT PANIC BUTTON (April 29, 1994)
  • K926029 — INFRA-LINK (March 26, 1993)
  • K921528 — HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM (April 20, 1992)
  • K902664 — HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 (July 25, 1990)

FDA data resources