CEREBRAL FUNCTION MONITOR 870— 510(k) K791580

Name: FDA 510(k) clearance K791580
Creator: U.S. Food and Drug Administration
Published: 1979-09-04

Substantially Equivalent

Applied Medical Research

FDA 510(k) clearance K791580 for CEREBRAL FUNCTION MONITOR 870, Substantially Equivalent on 1979-09-04. Applicant: Applied Medical Research. Device class: 2.

Clearance details

Applicant: Applied Medical Research
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1979-08-17
Decision date: 1979-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMA

view all

K192889 — Neo2020-01-30
K163644 — Nihon Kohden QP-160AK EEG Trend Program2017-05-19
K161027 — Cadwell AmpliScan2016-11-08
K152301 — Background Pattern Classification [BPc(TM)]2016-06-03
K130238 — NIHON KOHDEN AE-918P NEURO UNIT2015-03-04

More clearances from Applied Medical Research

view all

K800025 — DINAMAP RESEARCH MONITOR 12451980-02-01
K791159 — DINAMAP MODEL 8551979-07-30
K790322 — OPTIONAL ACCESSORY FOOT SWITCH MODEL 1001979-05-14
K790328 — MODEL 1051, MONITOR1979-03-02
K782073 — DINAMAP MODELS 1160 AND 11651979-02-23

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