OptoMonitor 3— 510(k) K193620

Name: FDA 510(k) clearance K193620
Creator: U.S. Food and Drug Administration
Published: 2020-06-18

Substantially Equivalent

Opsens, Inc.

FDA 510(k) clearance K193620 for OptoMonitor 3, Substantially Equivalent on 2020-06-18. Applicant: Opsens, Inc.. Device class: 2.

Clearance details

Applicant: Opsens, Inc.
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
Advisory panel: Cardiovascular
Date received: 2019-12-26
Decision date: 2020-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXO

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K251367 — OptoMonitor 32026-01-16
K241418 — OptoMonitor 32025-02-12
K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_2024-07-17
K222216 — TruWave Disposable Pressure Transducer2022-12-22
K202943 — OptoMonitor 32020-11-24

More clearances from Opsens, Inc.

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Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.