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510(k) K792305

A SLEEP ASSESSMENT DEVICE by Farrall Instruments, Inc. — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1979
Date Received
November 16, 1979
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 Farrall Instruments, Inc.

  • K940128 — CAT-400UL PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K936115 — CAT-600 PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K821723 — BI-4520 DUAL IMPEDOMETER (September 15, 1982)
  • K821664 — PP-100, PERSONAL PERINEOMETER (July 13, 1982)
  • K781634 — VISUALAX (October 3, 1978)
  • K760166 — STIMULATOR, SONIC CONTROL (AS-1) (July 20, 1976)

Other clearances for product code LEL

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  • 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)