OLYMPIC WARM-UP— 510(k) K001056

Name: FDA 510(k) clearance K001056
Creator: U.S. Food and Drug Administration
Published: 2000-09-29

Substantially Equivalent

Olympic Medical Corp.

FDA 510(k) clearance K001056 for OLYMPIC WARM-UP, Substantially Equivalent on 2000-09-29. Applicant: Olympic Medical Corp.. Device class: 2.

Clearance details

Applicant: Olympic Medical Corp.
Product code: Code ILY
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2000-04-03
Decision date: 2000-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILY

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More clearances from Olympic Medical Corp.

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K081094 — OLYMPIC PASTEURMATIC, MODELS 3000 AND 35002008-06-20
K031149 — OLYMPIC CFM 60002003-05-14
K020335 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 53302002-06-18
K983229 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM1999-03-23
K971601 — OLYMPIC BILI-BASSINET1997-09-24

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.