THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER— 510(k) K884158

Substantially Equivalent

Ppg Industries, Inc.

FDA 510(k) clearance K884158 for THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER, Substantially Equivalent on 1989-01-17. Applicant: Ppg Industries, Inc..

Clearance details

Applicant: Ppg Industries, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1988-10-04
Decision date: 1989-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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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.