510(k) K212161
- Device
- Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
- Applicant
- Masimo Corporation
- 510(k) number
- K212161
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-06
- Date received
- 2021-07-12
- Regulation
- 870.2300
- Classification name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Katelynn Kirby
- Address
- 52 Discovery Irvine CA US 92618 92618
FDA Registration Numbers
- 2221819
- 9710602
- 3004009431
- 3007615597
- 3031563234
- 3003174284
- 2027454
- 1054713
- 3004145393
- 8040537
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- 3002736372
- 3010692333
- 1651104
- 3032013079
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- 3012933969
- 3012103976
- 3005521864
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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