K102560 is an FDA 510(k) clearance for the REPROCESSED 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 February 18, 2011, 164 days after receiving the submission on September 7, 2010.
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 | K102560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2010 |
| Decision Date | February 18, 2011 |
| Days to Decision | 164 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). |