The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc (dba Medline with the FDA for Medline Renewal Reprocessed Oximax Pulse Oximetry Sensors.
| Device ID | K181738 |
| 510k Number | K181738 |
| Device Name: | Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors |
| Classification | Oximeter |
| Applicant | Surgical Instrument Service 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 ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888277722306 | K181738 | 000 |