INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)— 510(k) K941762

Substantially Equivalent

Hogan & Hartson

FDA 510(k) clearance K941762 for INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS), Substantially Equivalent on 1995-02-22. Applicant: Hogan & Hartson.

Clearance details

Applicant: Hogan & Hartson
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1994-04-11
Decision date: 1995-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.