MODIFICATION TO I VENT 201— 510(k) K061627

Substantially Equivalent

Versamed Medical Systems, Inc.

FDA 510(k) clearance K061627 for MODIFICATION TO I VENT 201, Substantially Equivalent on 2006-06-29. Applicant: Versamed Medical Systems, Inc..

Clearance details

Applicant: Versamed Medical Systems, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2006-06-12
Decision date: 2006-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Pearl River, NY, US

Download summary PDF View on FDA.gov ↗

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.