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FDA 510(k), K150314, Masimo MightySat Rx Fingertip Pulse Oximeter
FDA 510(k), K150314, Masimo MightySat Rx Fingertip Pulse Oximeter
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$89.00 USD
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510(K) Number: K150314
Device Name: Masimo MightySat Rx Fingertip Pulse Oximeter
Manufacturer: Marguerite Thomlinson
Device Classification Name: Oximeter
Regulation Number: DQA
Classification Product Code: KXA
Date Received: 02/09/2015
Decision Date: 10/22/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: Masimo MightySat Rx Fingertip Pulse Oximeter
Manufacturer: Marguerite Thomlinson
Device Classification Name: Oximeter
Regulation Number: DQA
Classification Product Code: KXA
Date Received: 02/09/2015
Decision Date: 10/22/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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