Home / 510(k) Clearances / K860914

510(k) K860914

ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV by Bio-Feedback Systems, Inc. — Product Code GWK

K860914 is an FDA 510(k) premarket notification submitted by Bio-Feedback Systems, Inc. for the device "ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV". The FDA issued a decision of Substantially Equivalent on June 6, 1986. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Bio-Feedback Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1986
Date Received
March 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
Submission Type

Other clearances by Bio-Feedback Systems, Inc.

  • K905372 — MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 (April 12, 1991)
  • K905373 — MINIATURE TEMPERATURE TRAINER MODEL DT-002 (April 10, 1991)
  • K900063 — MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) (February 16, 1990)
  • K832333 — FEEDBACK EMG SYSTEM PE-020 (September 1, 1983)
  • K812619 — ISOLATED VOLTAGE/FREQUENCY CONVERTER (October 8, 1981)
  • K792659 — FEEDBACK EDR SYSTEM MODEL ME-1 (January 9, 1980)
  • K771023 — ANALOG QUANTIFIER MODEL AQ-100 (June 24, 1977)
  • K770790 — FEEDBACK EDR SYSTEM MODEL EDR-100 (May 10, 1977)
  • K770663 — FEEDBACK EMG SYSTEM, MODEL PE-L00 (April 26, 1977)
  • K770270 — TEMPERATURE FEEDBACK SYS, MODEL DT100 (February 24, 1977)

Other clearances for product code GWK

  • K060919 — ACTICAL (September 22, 2006)
  • K061870 — VITALSENSE XHR (August 31, 2006)
  • K052489 — ACTIHEART (September 27, 2005)
  • K991045 — MINI-LOGGER SERIES 2000 (September 21, 1999)
  • K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 (June 28, 1991)
  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 18, 1991)
  • K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
  • K882599 — NICOLET BRAINLAB SYSTEM (October 19, 1988)
  • K872290 — BIO-LOGIC BANKER (October 6, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)

FDA data resources