The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for 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).
| Device ID | K222019 |
| 510k Number | K222019 |
| Device Name: | 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) |
| Classification | Oximeter, Reprocessed |
| Applicant | Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Contact | Michael Wong |
| Correspondent | Michael Wong Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-08 |
| Decision Date | 2022-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 57613327610579 | K222019 | 000 |
| 57613327610562 | K222019 | 000 |
| 57613327610555 | K222019 | 000 |
| 37613327610544 | K222019 | 000 |