ESORT II + 400 SERIES MONITOR— 510(k) K961138

Name: FDA 510(k) clearance K961138
Creator: U.S. Food and Drug Administration
Published: 1996-12-10

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K961138 for ESORT II + 400 SERIES MONITOR, Substantially Equivalent on 1996-12-10. 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: 1996-03-21
Decision date: 1996-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arleta, CA, US

Download summary PDF View on FDA.gov ↗

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