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510(k) K926029

INFRA-LINK by Zygo Industries, Inc. — Product Code IQA

K926029 is an FDA 510(k) premarket notification submitted by Zygo Industries, Inc. for the device "INFRA-LINK". The FDA issued a decision of Substantially Equivalent on March 26, 1993. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Zygo Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1993
Date Received
December 1, 1992
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 Zygo Industries, Inc.

  • K924014 — SECRETARY (March 4, 1993)
  • K924030 — SCRIBE (March 4, 1993)
  • K924013 — MACAW (March 4, 1993)
  • K924015 — PARROT (March 4, 1993)
  • K862766 — EPISON, ALERTING SYSTEM FOR EPILEPTICS (March 13, 1987)

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)
  • 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