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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 hands Masimo first clearance for medical-grade OTC pulse ox

Masimo Corp. received a pinch of good news with the U.S. FDA’s clearance of its medical-grade fingertip pulse oximeter, Mightysat Medical, for over-the-counter (OTC) sale. The device uses the same technology as Masimo’s Set pulse oximetry used in hospitals and clinics.

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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.

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Masimo Announces the First FDA-cleared "Over-the-Counter" Fingertip Pulse Oximeter -February 13, 2024 at 09:11 am EST

Masimo MightySat® Medical Provides Clinically Proven Masimo SET® Pulse Oximetry to Consumers for Medical Use Without a Prescription

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Masimo Corp. (MASI) Announces FDA Clearance of MightySat Medical

Masimo Corp. (MASI) Announces FDA Clearance of MightySat Medical
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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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FDA clears first over-the-counter pulse oximeter from Masimo

Masimo (Nasdaq: MASI) announced today that it received FDA clearance for its MightySat Medical over-the-counter fingertip pulse oximeter.

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