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Parker Quality & Compliance

PQC Reg Watch

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Device type

Amplifier, Physiological Signal

Product code GWL · Class II · 21 CFR 882.1835 · Neurology

FDA classification database

Recent 510(k)s

Oct 30, 2026

K260648

PolySense

Itamar Medical , Ltd.

Recent recalls

No recalls in the archive for GWL.