ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413— 510(k) K000660

Name: FDA 510(k) clearance K000660
Creator: U.S. Food and Drug Administration
Published: 2000-03-28

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K000660 for ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413, Substantially Equivalent on 2000-03-28. Applicant: Medical Data Electronics. Device class: 2.

Clearance details

Applicant: Medical Data Electronics
Product code: Code DRO
Device class: Class 2
Regulation: 21 CFR 870.5550
Advisory panel: Cardiovascular
Date received: 2000-02-28
Decision date: 2000-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Arleta, CA, US

Download summary PDF View on FDA.gov ↗

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