The following data is part of a premarket notification filed by Surgical Instrument Service And Savings Inc with the FDA for Medline Renewal Reprocessed Masimo Lncs Series Adult And Pediatric Spo2 Adhesive Sensors.
| Device ID | K191018 |
| 510k Number | K191018 |
| Device Name: | Medline ReNewal Reprocessed Masimo LNCS Series Adult And Pediatric SpO2 Adhesive Sensors |
| Classification | Oximeter, Reprocessed |
| 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 | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-17 |
| Decision Date | 2019-07-03 |