PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400— 510(k) K945985

Substantially Equivalent

Burdick, Inc.

FDA 510(k) clearance K945985 for PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400, Substantially Equivalent on 1995-07-03. Applicant: Burdick, Inc..

Clearance details

Applicant: Burdick, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1994-12-08
Decision date: 1995-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miltoon, WI, 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.