DeviceClearance

CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX— 510(k) K082268

Substantially Equivalent

Oridion Capnography, Inc.

FDA 510(k) clearance K082268 for CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX, Substantially Equivalent on 2009-02-06. Applicant: Oridion Capnography, Inc.. Device class: 2.

Clearance details

Applicant
Oridion Capnography, Inc.
Product code
Code DQA
Device class
Class 2
Regulation
21 CFR 870.2700
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jerusalem, IL
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQA

product code DQA
Death
66
Malfunction
2,867
Other
1
Total
2,934

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 →

Recalls naming K082268

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082268.

Data sourced from openFDA. This site is unofficial and independent of the FDA.