ANS 2000 ECG MONITOR AND RESPIRATION PACER— 510(k) K973426

Substantially Equivalent

D. E. Hokanson, Inc.

FDA 510(k) clearance K973426 for ANS 2000 ECG MONITOR AND RESPIRATION PACER, Substantially Equivalent on 1998-08-12. Applicant: D. E. Hokanson, Inc..

Clearance details

Applicant: D. E. Hokanson, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1997-09-10
Decision date: 1998-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.