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510(k) K781634

VISUALAX by Farrall Instruments, Inc. — Product Code HCC

K781634 is an FDA 510(k) premarket notification submitted by Farrall Instruments, Inc. for the device "VISUALAX". The FDA issued a decision of Substantially Equivalent on October 3, 1978. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Farrall Instruments, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1978
Date Received
September 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
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)
  • K792305 — A SLEEP ASSESSMENT DEVICE (December 20, 1979)
  • K760166 — STIMULATOR, SONIC CONTROL (AS-1) (July 20, 1976)

Other clearances for product code HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 2015)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)

FDA data resources