K201699 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor. This device is classified as a Oximeter, Reprocessed (Class II - Special Controls, product code NLF).
Submitted by Surgical Instrument and Savings Inc (Dba Medline Renewal) (Redmond, US). The FDA issued a Cleared decision on July 22, 2020, 30 days after receiving the submission on June 22, 2020.
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 | K201699 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2020 |
| Decision Date | July 22, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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). |