MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM— 510(k) K002544

Substantially Equivalent

Oxford Instruments

FDA 510(k) clearance K002544 for MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM, Substantially Equivalent on 2000-09-13. Applicant: Oxford Instruments.

Clearance details

Applicant: Oxford Instruments
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2000-08-17
Decision date: 2000-09-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Old Woking, Surrey, GB

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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.