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FDA Clears Over-the-Counter Pulse Oximeter

Over-the-counter option was designed for home monitoring by adults aged 18 years and older.

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FDA clears 1st OTC pulse oximeter for home use as medical device

FDA clears 1st OTC pulse oximeter for home use as medical device
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FDA Clears MightySat Medical Fingertip Pulse Oximeter for OTC Use

The FDA has cleared Masimo MightySat Medical, an over-the-counter (OTC) medical fingertip pulse oximeter.

Masimo mightysatDrug administrationSat medical

FDA Clears Fingertip Pulse Oximeter for Over-the-Counter Use

The US Food and Drug Administration granted 510(k) clearance to Masimo’s MightySat Medical fingertip pulse oximeter for over-the-counter use.

Peter pronovostJoe kianiDrug administrationUniversity hospitalsMightysat medicalSat medical

Masimo Announces the First FDA-cleared Over-the-Counter Fingertip Pulse Oximeter Seite 1

13.02.2024 - Masimo (NASDAQ: MASI) announced today FDA clearance of MightySat Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available Over-The-Counter (OTC) direct to consumers without a prescription. All other pulse . Seite 1

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