DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX— 510(k) K910771

Name: FDA 510(k) clearance K910771
Creator: U.S. Food and Drug Administration
Published: 1991-12-18

Substantially Equivalent

New England Medical Instruments, Inc.

FDA 510(k) clearance K910771 for DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX, Substantially Equivalent on 1991-12-18. Applicant: New England Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: New England Medical Instruments, Inc.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1991-02-22
Decision date: 1991-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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