CAPNOPROBE SL, MODEL 2000— 510(k) K010795

Name: FDA 510(k) clearance K010795
Creator: U.S. Food and Drug Administration
Published: 2001-04-11

Substantially Equivalent

Optical Sensors, Inc.

FDA 510(k) clearance K010795 for CAPNOPROBE SL, MODEL 2000, Substantially Equivalent on 2001-04-11. Applicant: Optical Sensors, Inc.. Device class: 2.

Clearance details

Applicant: Optical Sensors, Inc.
Product code: Code CCK
Device class: Class 2
Regulation: 21 CFR 868.1400
Advisory panel: Anesthesiology
Date received: 2001-03-16
Decision date: 2001-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Stoughton, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.