Vivo 45 LS— 510(k) K232365

Name: FDA 510(k) clearance K232365
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Substantially Equivalent

Oconnell Regulatory Consultants, Inc.

FDA 510(k) clearance K232365 for Vivo 45 LS, Substantially Equivalent on 2025-12-19. Applicant: Oconnell Regulatory Consultants, Inc.. Device class: 2.

Clearance details

Applicant: Oconnell Regulatory Consultants, Inc.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2023-08-07
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoneham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.