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510(k) K943244

DEUCE by Apt Technology, Inc. — Product Code IQA

K943244 is an FDA 510(k) premarket notification submitted by Apt Technology, Inc. for the device "DEUCE". The FDA issued a decision of Substantially Equivalent on September 11, 1995. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Apt Technology, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1995
Date Received
July 6, 1994
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 by Apt Technology, Inc.

  • K953937 — LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM (October 31, 1995)

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)
  • 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)
  • K911101 — TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM (April 25, 1991)
  • K902664 — HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 (July 25, 1990)

FDA data resources