DeviceClearance

Aisys CS2— 510(k) K170872

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K170872 for Aisys CS2, Substantially Equivalent on 2017-08-15. Applicant: Datex-Ohmeda, Inc.. Device class: 2.

Clearance details

Applicant
Datex-Ohmeda, Inc.
Product code
Code BSZ
Device class
Class 2
Regulation
21 CFR 868.5160
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Madison, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BSZ

product code BSZ
Death
23
Injury
298
Malfunction
32,987
Total
33,308

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 K170872

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 K170872.

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