MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE— 510(k) K072420

Name: FDA 510(k) clearance K072420
Creator: U.S. Food and Drug Administration
Published: 2008-01-22

Substantially Equivalent

Oceanic Medical Products, Inc.

FDA 510(k) clearance K072420 for MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE, Substantially Equivalent on 2008-01-22. Applicant: Oceanic Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Oceanic Medical Products, Inc.
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
Advisory panel: Anesthesiology
Date received: 2007-08-28
Decision date: 2008-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Oceanic Medical Products, Inc.

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K060193 — MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 22006-04-10
K010613 — MAGELLAN-2200, MODEL 12001-10-12
K002951 — MAGELLAN VENTILATOR2000-12-08

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.