FDA.report

510(k) K221953

Device
Masimo CARESCAPE SpO2 – Masimo With SpHb
Applicant
Masimo Corporation
510(k) number
K221953
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-04
Date received
2022-07-05
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Unji Lee
Address
52 Discovery Irvine CA US 92618 92618

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00843997010818rainbow SETMASIMO CORPORATION2022-11-21

Legacy Summary

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FDA Review

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