STIMUPLEX-DIG-RC NERVE STIMULATOR— 510(k) K021033

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code BXN

Device class

Class 2

Regulation

21 CFR 868.2775

Advisory panel

Anesthesiology

Date received

2002-03-29

Decision date

2003-03-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Allentown, PA, US

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Other

1

Total

1

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 →