THERMAL JACKET FOR I.V. FLUID BAGS— 510(k) K870113

Name: FDA 510(k) clearance K870113
Creator: U.S. Food and Drug Administration
Published: 1987-02-25

Substantially Equivalent

Thermal Medical Systems, Inc.

FDA 510(k) clearance K870113 for THERMAL JACKET FOR I.V. FLUID BAGS, Substantially Equivalent on 1987-02-25. Applicant: Thermal Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Thermal Medical Systems, Inc.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1987-01-12
Decision date: 1987-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Astoria, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.