EPISENSOR— 510(k) K903224

Name: FDA 510(k) clearance K903224
Creator: U.S. Food and Drug Administration
Published: 1990-12-24

Substantially Equivalent

Palex Intl. SA

FDA 510(k) clearance K903224 for EPISENSOR, Substantially Equivalent on 1990-12-24. Applicant: Palex Intl. SA. Device class: 2.

Clearance details

Applicant: Palex Intl. SA
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 1990-07-23
Decision date: 1990-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spain, ES

Download summary PDF View on FDA.gov ↗

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K905108 — CONTORNO(R), MODELS E AND ST1991-02-04
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K902642 — CONTORNO (TM)1990-08-07
K901680 — BAUMAN RIGID LARYNGOSCOPE1990-07-12

Adverse events under product code BSP

product code BSP

Death: 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.