FDA 510(K) K050833, LECTRODE JUNCTION BOX, MODEL JE-921A
FDA 510(K) K050833, LECTRODE JUNCTION BOX, MODEL JE-921A
Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K050833
Device Name ELECTRODE JUNCTION BOX, MODEL JE-921A
Applicant NIHON KOHDEN AMERICA, INC.
Regulation Number 882.1400
Classification Product Code OLV
Subsequent Product Code GWQ
Date Received 04/01/2005
Decision Date 04/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
Total pages: 292
Fully redacted pages: 151
Content pages: 141
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