SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC— 510(k) K012229

Substantially Equivalent

National Custom Ent., Inc.

FDA 510(k) clearance K012229 for SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC, Substantially Equivalent on 2001-09-10. Applicant: National Custom Ent., Inc..

Clearance details

Applicant: National Custom Ent., Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 2001-07-16
Decision date: 2001-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnsville, MN, US

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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.