CALDYNE, INC. EXHALOMETER EX100, MODEL EX100— 510(k) K051279

Substantially Equivalent

Caldyne, Inc.

FDA 510(k) clearance K051279 for CALDYNE, INC. EXHALOMETER EX100, MODEL EX100, Substantially Equivalent on 2005-09-07. Applicant: Caldyne, Inc..

Clearance details

Applicant: Caldyne, Inc.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 2005-05-17
Decision date: 2005-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.