BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV— 510(k) K884848

Name: FDA 510(k) clearance K884848
Creator: U.S. Food and Drug Administration
Published: 1989-02-02

Substantially Equivalent

Moe

FDA 510(k) clearance K884848 for BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV, Substantially Equivalent on 1989-02-02. Applicant: Moe. Device class: 2.

Clearance details

Applicant: Moe
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1988-11-18
Decision date: 1989-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Soquel, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCC

view all

K233580 — A Breathing System (ABS)2024-08-01
K222101 — Prism2023-03-17
K180173 — Freespira2018-08-23
K163448 — GrindCare System2017-09-01
K151050 — Pacifier Activated Lullaby (PAL®)2015-12-22

More clearances from Moe

view all

K884849 — BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR1989-03-23
K884851 — BIOFEEDBACK DEVICE TG3, TG41989-02-03
K884850 — BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA301989-02-02
K884852 — BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.1989-02-02
K884853 — BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC11989-02-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.