K072194 is an FDA 510(k) clearance for the RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25. 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 November 29, 2007, 114 days after receiving the submission on August 7, 2007.
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 | K072194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2007 |
| Decision Date | November 29, 2007 |
| Days to Decision | 114 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). |