APPLIDYN— 510(k) K864581

Name: FDA 510(k) clearance K864581
Creator: U.S. Food and Drug Administration
Published: 1987-01-21

Substantially Equivalent

Grandcor Medical Systems

FDA 510(k) clearance K864581 for APPLIDYN, Substantially Equivalent on 1987-01-21. Applicant: Grandcor Medical Systems. Device class: 2.

Clearance details

Applicant: Grandcor Medical Systems
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 1986-11-20
Decision date: 1987-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, US

Download summary PDF View on FDA.gov ↗

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K905480 — SPIROSCOPE1991-05-06
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K871890 — CARDIO-MEGA SYSTEM1987-06-12
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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.