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510(k) K791580

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

K791580 is an FDA 510(k) premarket notification submitted by Applied Medical Research for the device "CEREBRAL FUNCTION MONITOR 870". The FDA issued a decision of Substantially Equivalent on September 4, 1979. The device falls under product code OMA (Amplitude-Integrated Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Applied Medical Research has at least 10 other 510(k) clearances on record.

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)

FDA data resources