DeviceClearance

OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M— 510(k) K053407

Substantially Equivalent

Analytical Industries, Inc.

FDA 510(k) clearance K053407 for OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M, Substantially Equivalent on 2006-04-05. Applicant: Analytical Industries, Inc.. Device class: 2.

Clearance details

Applicant
Analytical Industries, 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
Traditional
Location
Pomona, CA, 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.