MUSCLE RESPONSE MONITOR— 510(k) K971400

Substantially Equivalent

Enriching Your Life

FDA 510(k) clearance K971400 for MUSCLE RESPONSE MONITOR, Substantially Equivalent on 1998-04-14. Applicant: Enriching Your Life. Device class: 2.

Clearance details

Applicant: Enriching Your Life
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1997-04-15
Decision date: 1998-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Granbury, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCC

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

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