ExSpiron 2Xi— 510(k) K192595

Name: FDA 510(k) clearance K192595
Creator: U.S. Food and Drug Administration
Published: 2019-12-17

Substantially Equivalent

Respiratory Motion

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

Clearance details

Applicant: Respiratory Motion
Product code: Code BZK
Device class: Class 2
Regulation: 21 CFR 868.1850
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 ↗

Recent devices under product code BZK

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K192584 — BEACON Caresystem Model 000021442019-12-18
K180788 — Gas Module 32018-10-24
K173181 — ExSpiron 1Xi2018-03-16
K162131 — ExSpiron 1Xi2017-05-09
K130170 — EXSPIRON 1XI2013-05-29

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.