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Dolphin Medical, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
12

What Dolphin Medical, Inc. makes

Dolphin Medical, Inc. manufactures pulse oximetry devices, including standalone oximeters, handheld units, and a range of reusable and disposable oximetry sensors for adults, pediatric, infant, and neonatal patients. The portfolio includes sensors compatible with third-party systems like Nellcor and Datex, as well as standalone models with digital interfaces. Sensors are designed for forehead, finger, and other attachment sites, supporting continuous or intermittent monitoring.

The company’s devices are classified as Class II under FDA regulations and are recorded in the FDA’s 510(k) clearance database. The portfolio is listed in the U.S. market, where Dolphin Medical, Inc. is based.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Dolphin Medical, Inc. have in the registry?

The registry currently lists 12 devices for Dolphin Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dolphin Medical, Inc.'s devices?

Among its 12 most recently registered devices, Dolphin Medical, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Dolphin Medical, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Dolphin Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Dolphin Medical, Inc. in the registry?

The most recently registered devices listed for Dolphin Medical, Inc. include DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421, DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER, DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER and DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420.

Generated automatically from registry data and not verified by a human reviewer.