OSCAR(TM) PB255 OXIMETER CAPNOMETER— 510(k) K872760

Name: FDA 510(k) clearance K872760
Creator: U.S. Food and Drug Administration
Published: 1987-09-14

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K872760 for OSCAR(TM) PB255 OXIMETER CAPNOMETER, Substantially Equivalent on 1987-09-14. Applicant: Datex Division Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Product code CCK
Device class: Class 2
Regulation: 21 CFR 868.1400
Advisory panel: Anesthesiology
Date received: 1987-07-13
Decision date: 1987-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.