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510(k) K890596

MED-A-CALL ASSIST DEVICE by Silent Call Corp. — Product Code IQA

K890596 is an FDA 510(k) premarket notification submitted by Silent Call Corp. for the device "MED-A-CALL ASSIST DEVICE". The FDA issued a decision of Substantially Equivalent on March 14, 1989. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Silent Call Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1989
Date Received
January 27, 1989
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 Silent Call Corp.

  • K890445 — PERSONAL ALERT ASSIST DEVICE (May 19, 1989)

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