K191018 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors. This device is classified as a Oximeter, Reprocessed (Class II - Special Controls, product code NLF).
Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on July 3, 2019, 77 days after receiving the submission on April 17, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700. 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)..
| 510(k) Number | K191018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2019 |
| Decision Date | July 03, 2019 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NLF — Oximeter, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |
| Definition | 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). |