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

Clearance details

Applicant

National Custom Ent., Inc.

Product code

Code FMT

Device class

Class 2

Regulation

21 CFR 880.5130

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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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 →