DATA RECORDER— 510(k) K910118

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K910118 for DATA RECORDER, Substantially Equivalent on 1991-02-14. Applicant: Healthdyne, Inc..

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1991-01-11
Decision date: 1991-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Snellville, GA, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.