DeviceClearance

INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)— 510(k) K984295

Substantially Equivalent

Invacare Corp.

FDA 510(k) clearance K984295 for INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS), Substantially Equivalent on 1999-07-09. Applicant: Invacare Corp.. Device class: 2.

Clearance details

Applicant
Invacare Corp.
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
Elyria, OH, 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.