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510(k) K792659

FEEDBACK EDR SYSTEM MODEL ME-1 by Bio-Feedback Systems, Inc. — Product Code HCC

K792659 is an FDA 510(k) premarket notification submitted by Bio-Feedback Systems, Inc. for the device "FEEDBACK EDR SYSTEM MODEL ME-1". The FDA issued a decision of Substantially Equivalent on January 9, 1980. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Bio-Feedback Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1980
Date Received
December 26, 1979
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 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)
  • K860914 — ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV (June 6, 1986)
  • K832333 — FEEDBACK EMG SYSTEM PE-020 (September 1, 1983)
  • K812619 — ISOLATED VOLTAGE/FREQUENCY CONVERTER (October 8, 1981)
  • 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 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