K041127 is an FDA 510(k) clearance for the MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS. This device is classified as a Oximeter, Reprocessed (Class II - Special Controls, product code NLF).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 23, 2004, 146 days after receiving the submission on April 30, 2004.
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 | K041127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2004 |
| Decision Date | September 23, 2004 |
| Days to Decision | 146 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). |