DM100 (DISTAL MONITOR - 100)— 510(k) K884135

Substantially Equivalent

Bio.Logic, Inc.

FDA 510(k) clearance K884135 for DM100 (DISTAL MONITOR - 100), Substantially Equivalent on 1989-01-17. Applicant: Bio.Logic, Inc.. Device class: 2.

Clearance details

Applicant: Bio.Logic, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1988-09-30
Decision date: 1989-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spokane, WA, US

Download summary PDF View on FDA.gov ↗

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