D100 COMPUTER CARDIAC ANALYSIS SYSTEM— 510(k) K863231

Name: FDA 510(k) clearance K863231
Creator: U.S. Food and Drug Administration
Published: 1986-11-25

Substantially Equivalent

Dextra Medical, Inc.

FDA 510(k) clearance K863231 for D100 COMPUTER CARDIAC ANALYSIS SYSTEM, Substantially Equivalent on 1986-11-25. Applicant: Dextra Medical, Inc.. Device class: 2.

Clearance details

Applicant: Dextra Medical, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1986-08-21
Decision date: 1986-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Beach, CA, US

Download summary PDF View on FDA.gov ↗

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K863230 — D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM1986-11-25

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