The following data is part of a premarket notification filed by Surgical Instrument And Savings Inc (dba Medline Renewal) with the FDA for Medline Renewal Reprocessed Nellcor Oximax Spo2 Sensor.
| Device ID | K201699 |
| 510k Number | K201699 |
| Device Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor |
| Classification | Oximeter, Reprocessed |
| Applicant | Surgical Instrument And Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave Redmond, OR 97756 |
| Contact | Stephanie Boyle Mays |
| Correspondent | Stephanie Boyle Mays Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Ave Redmond, OR 97756 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2020-07-22 |