510(k) K791580

CEREBRAL FUNCTION MONITOR 870 by Applied Medical Research — Product Code OMA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 4, 1979
Date Received: August 17, 1979
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Amplitude-Integrated Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

Other clearances by Applied Medical Research

K800025 — DINAMAP RESEARCH MONITOR 1245 (February 1, 1980)
K791159 — DINAMAP MODEL 855 (July 30, 1979)
K790322 — OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 (May 14, 1979)
K790328 — MODEL 1051, MONITOR (March 2, 1979)
K782073 — DINAMAP MODELS 1160 AND 1165 (February 23, 1979)
K781064 — DINAMAP MODEL 848 (September 7, 1978)
K781053 — DINAMAP MODEL 846 (September 7, 1978)
K781311 — ELECTRODE, NEEDLE, CFM (August 21, 1978)
K780754 — NEONATAL MONITOR (June 14, 1978)
K780759 — MODEL 902 STAND (May 19, 1978)

Other clearances for product code OMA

K192889 — Neo (January 30, 2020)
K163644 — Nihon Kohden QP-160AK EEG Trend Program (May 19, 2017)
K161027 — Cadwell AmpliScan (November 8, 2016)
K152301 — Background Pattern Classification [BPc(TM)] (June 3, 2016)
K130238 — NIHON KOHDEN AE-918P NEURO UNIT (March 4, 2015)
K131789 — CEREBRALOGIK- AEEG (December 27, 2013)
K123079 — OLYMPIC BRAINZ MONITOR (May 8, 2013)
K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AN (March 16, 2012)
K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM (July 9, 2010)
K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)