MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC— 510(k) K012264

Substantially Equivalent

National Custom Ent., Inc.

FDA 510(k) clearance K012264 for MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC, Substantially Equivalent on 2001-10-10. Applicant: National Custom Ent., Inc..

Clearance details

Applicant: National Custom Ent., Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2001-07-18
Decision date: 2001-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnsville, MN, 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.