ADULT-PEDIATRIC TRANSPORT SYSTEM— 510(k) K955766

Name: FDA 510(k) clearance K955766
Creator: U.S. Food and Drug Administration
Published: 1996-08-07

Substantially Equivalent

International Biomedical, Inc.

FDA 510(k) clearance K955766 for ADULT-PEDIATRIC TRANSPORT SYSTEM, Substantially Equivalent on 1996-08-07. Applicant: International Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: International Biomedical, Inc.
Product code: Code FPO
Device class: Class 2
Regulation: 21 CFR 880.6910
Advisory panel: General Hospital
Date received: 1995-12-20
Decision date: 1996-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FPO

product code FPO

Death: 29
Injury: 254
Malfunction: 5,054
Other: 10
Total: 5,347

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.