DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Sensidyne, Inc.
Product code
Code CCL
Device class
Class 2
Regulation
21 CFR 868.1720
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Clearwater, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CCL

product code CCL
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.