THE BAGNOLI-2 EMG SYSTEM— 510(k) K945286

Substantially Equivalent

Delsys, Inc.

FDA 510(k) clearance K945286 for THE BAGNOLI-2 EMG SYSTEM, Substantially Equivalent on 1995-09-15. Applicant: Delsys, Inc.. Device class: 2.

Clearance details

Applicant: Delsys, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1994-10-31
Decision date: 1995-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, 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.