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510(k) K944345

BEDSIDE BUTLER by Trac Medical, Inc. — Product Code IQA

K944345 is an FDA 510(k) premarket notification submitted by Trac Medical, Inc. for the device "BEDSIDE BUTLER". The FDA issued a decision of Substantially Equivalent on October 17, 1994. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Trac Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1994
Date Received
September 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 Trac Medical, Inc.

  • K933431 — ORTHOTRAC COAXIAL LASER (October 5, 1993)

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)
  • 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