ExSpiron 2Xi— 510(k) K192595

Substantially Equivalent

Respiratory Motion

FDA 510(k) clearance K192595 for ExSpiron 2Xi, Substantially Equivalent on 2019-12-17. Applicant: Respiratory Motion.

Clearance details

Applicant: Respiratory Motion
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 2019-09-20
Decision date: 2019-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Watertown, 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.