ExSpiron 1Xi— 510(k) K173181

Substantially Equivalent

Respiratory Motion, Inc.

FDA 510(k) clearance K173181 for ExSpiron 1Xi, Substantially Equivalent on 2018-03-16. Applicant: Respiratory Motion, Inc..

Clearance details

Applicant: Respiratory Motion, Inc.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 2017-09-29
Decision date: 2018-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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.