PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200— 510(k) K000206

Clearance details

Applicant

Axelgaard Mfg. Co., Ltd.

Product code

Code DRX

Device class

Class 2

Regulation

21 CFR 870.2360

Advisory panel

Cardiovascular

Date received

2000-01-21

Decision date

2000-04-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fallbrook, CA, US

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Death

6

Injury

476

Other

2

Total

484

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 →