510(k) K212555
K212555 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC". The FDA issued a decision of Substantially Equivalent on May 6, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Covidien, LLC has 224 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2022
- Date Received
- Aug 13, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type
- 510(k)