INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
FDA 510(k) K211561 · Covidien, LLC
510(k) numberK211561
Submission
- Device name
- INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
- Applicant
- Covidien, LLC
Boulder, CO, US - Received
- May 20, 2021
- Decision date
- December 5, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUD – Oximeter, Tissue Saturation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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|---|---|---|---|
| K254129 | Spectrum-2MUD · Traditional | Neko Health AB | 05/22/2026SE |
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| K230612 | Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional | Edwards Lifesciences, LLC | 11/17/2023SE |
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Questions and answers
When was INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) cleared by the FDA?
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) (K211561) received a 510(k) decision of Substantially Equivalent on December 5, 2021, 199 days after the submission was received.
What is the product code of K211561?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.