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Masimo’s MightySat Receives First FDA Clearance For OTC Pulse Oximeter

 
• By Hannah Daniel

The first clearance from the US Food and Drug Administration for an over-the-counter fingertip pulse oximeter has gone to Masimo's MightySat Medical, which is now available at the company's website.

• Source: Shutterstock

Masimo is launching MightySat Medical, the first over-the-counter fingertip pulse oximeter to receive clearance from the US Food and Drug Administration.

The device, which costs $299, was ruled as substantially equivalent to Masimo’s prescription pulse oximeter

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