SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.— 510(k) K965070

Name: FDA 510(k) clearance K965070
Creator: U.S. Food and Drug Administration
Published: 1997-03-06

Substantially Equivalent

Mecta Corp.

FDA 510(k) clearance K965070 for SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M., Substantially Equivalent on 1997-03-06. Applicant: Mecta Corp.. Device class: 2.

Clearance details

Applicant: Mecta Corp.
Product code: Code QGH
Device class: Class 2
Regulation: 21 CFR 882.5940
Advisory panel: Neurology
Date received: 1996-12-11
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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