EXSPIRON 1XI— 510(k) K130170

Name: FDA 510(k) clearance K130170
Creator: U.S. Food and Drug Administration
Published: 2013-05-29

Substantially Equivalent

Respiratory Motion, Inc.

FDA 510(k) clearance K130170 for EXSPIRON 1XI, Substantially Equivalent on 2013-05-29. Applicant: Respiratory Motion, Inc.. Device class: 2.

Clearance details

Applicant: Respiratory Motion, Inc.
Product code: Code BZK
Device class: Class 2
Regulation: 21 CFR 868.1850
Advisory panel: Anesthesiology
Date received: 2013-01-24
Decision date: 2013-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BZK

product code BZK

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.