100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I— 510(k) K010382

Substantially Equivalent

Sensidyne, Inc.

FDA 510(k) clearance K010382 for 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I, Substantially Equivalent on 2001-03-01. Applicant: Sensidyne, Inc..

Clearance details

Applicant: Sensidyne, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 2001-02-08
Decision date: 2001-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Clearwater, FL, US

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Adverse events under product code CCL

product code CCL

Other: 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.