PERIPHERAL NERVE STIMULATOR MODEL A400— 510(k) K852962

Clearance details

Applicant

Fisher & Paykel Allied Products , Ltd.

Product code

Code BXN

Device class

Class 2

Regulation

21 CFR 868.2775

Advisory panel

Anesthesiology

Date received

1985-07-12

Decision date

1985-12-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Auckland, New Zealand, NZ

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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 →