MODIFICATION TO ZYMED HOLTER 2000— 510(k) K992197

Name: FDA 510(k) clearance K992197
Creator: U.S. Food and Drug Administration
Published: 1999-07-28

Substantially Equivalent

Zymed Medical Instrumentation

FDA 510(k) clearance K992197 for MODIFICATION TO ZYMED HOLTER 2000, Substantially Equivalent on 1999-07-28. Applicant: Zymed Medical Instrumentation. Device class: 2.

Clearance details

Applicant: Zymed Medical Instrumentation
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1999-06-30
Decision date: 1999-07-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Camarillo, CA, 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.