SUBOCCIPITAL ICE PILLOW— 510(k) K882413

Name: FDA 510(k) clearance K882413
Creator: U.S. Food and Drug Administration
Published: 1988-11-30

Substantially Equivalent

Ferguson Medical

FDA 510(k) clearance K882413 for SUBOCCIPITAL ICE PILLOW, Substantially Equivalent on 1988-11-30. Applicant: Ferguson Medical. Device class: 1.

Clearance details

Applicant: Ferguson Medical
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1988-06-13
Decision date: 1988-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chico, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IME

product code IME

Other: 1
Total: 1

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.