DMR/CO2 COMBO KTI— 510(k) K960468

Name: FDA 510(k) clearance K960468
Creator: U.S. Food and Drug Administration
Published: 1996-04-26

Unknown

Nellcor Puritan Bennett, Inc.

FDA 510(k) clearance K960468 for DMR/CO2 COMBO KTI, Unknown on 1996-04-26. Applicant: Nellcor Puritan Bennett, Inc.. Device class: 2.

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1996-02-01
Decision date: 1996-04-26
Decision: Unknown
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.