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510(k) K900969

REMOTE CONTROL SWITCH by Baylor Biomedical Services — Product Code IQA

K900969 is an FDA 510(k) premarket notification submitted by Baylor Biomedical Services for the device "REMOTE CONTROL SWITCH". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Baylor Biomedical Services has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
March 2, 1990
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 Baylor Biomedical Services

  • K901029 — YES-NO VOICE BOX 7011 (March 13, 1990)
  • K901030 — ROTARY COMMUNICATION SCANNER MODEL 7010 (March 13, 1990)
  • K901028 — ENVIRONMENTAL CONTROL UNIT MODEL 7000 (March 13, 1990)

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)
  • K911101 — TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM (April 25, 1991)

FDA data resources