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510(k) K902664

HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 by Prentke Romich Co. — Product Code IQA

K902664 is an FDA 510(k) premarket notification submitted by Prentke Romich Co. for the device "HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1". The FDA issued a decision of Substantially Equivalent on July 25, 1990. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Prentke Romich Co. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1990
Date Received
June 18, 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 Prentke Romich Co.

  • K961306 — DELTATALKER WITH INFRARED (June 27, 1996)
  • K944585 — SCANNING DIRECTOR (February 21, 1995)
  • K933207 — WALKERTALKER (March 28, 1994)
  • K935317 — ALPHA TALKER (March 28, 1994)
  • K925387 — LIBERATOR (March 29, 1993)
  • K925527 — LIGHT TALKER (March 22, 1993)
  • K914259 — TOUCH TALKER (February 27, 1992)
  • K902206 — CONTROL 1 ENVIRONMENTAL CONTROL (May 29, 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