Home / 510(k) Clearances / K862766

510(k) K862766

EPISON, ALERTING SYSTEM FOR EPILEPTICS by Zygo Industries, Inc. — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1987
Date Received
July 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Zygo Industries, Inc.

  • K926029 — INFRA-LINK (March 26, 1993)
  • K924030 — SCRIBE (March 4, 1993)
  • K924015 — PARROT (March 4, 1993)
  • K924013 — MACAW (March 4, 1993)
  • K924014 — SECRETARY (March 4, 1993)

Other clearances for product code LEL

  • K252981 — EmbraceMini (December 22, 2025)
  • K251574 — Sleep Watch (July 31, 2025)
  • K243513 — DCM (PW-DCM) (April 16, 2025)
  • K233987 — VERABAND™ (June 17, 2024)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) (June 23, 2023)
  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)
  • K151784 — ActTrust (May 25, 2016)
  • K132764 — MOTION WATCH AND PRO-DIARY (January 21, 2014)
  • K111514 — SBV2, MULTICHARGER MODEL MC10V2 (December 16, 2011)