510(k) K222019
K222019 is an FDA 510(k) premarket notification submitted by Stryker Sustainability Solutions for the device "Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)". The FDA issued a decision of Substantially Equivalent on December 4, 2022. The device falls under product code NLF (Oximeter, Reprocessed), a Class II device regulated under 21 CFR 870.2700. Stryker Sustainability Solutions has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2022
- Date Received
- July 8, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter, Reprocessed
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type
same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).