K063661 is an FDA 510(k) clearance for the RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20. This device is classified as a Oximeter, Reprocessed (Class II - Special Controls, product code NLF).
Submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on May 25, 2007, 168 days after receiving the submission on December 8, 2006.
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 | K063661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2006 |
| Decision Date | May 25, 2007 |
| Days to Decision | 168 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). |