FDA Device Intelligence
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WowGoHealth Pulse Oximeter GSH601

GOLDEN SMART HOME TECHNOLOGY CORP. · Model GSH601 · UDI-DI 04719878124010

OCH
0
510(k) clearances
35
Adverse events
0
Recalls
58
Facilities

Description

The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.