K083719 is an FDA 510(k) clearance for the LNCS OXIMETRY SENSORS. This device is classified as a Oximeter, Reprocessed (Class II - Special Controls, product code NLF).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on July 30, 2009, 227 days after receiving the submission on December 15, 2008.
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 | K083719 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2008 |
| Decision Date | July 30, 2009 |
| Days to Decision | 227 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). |