Oximeter, Tissue Saturation, Reprocessed
FDA product code NMD · Class II (moderate risk) · 21 CFR 870.2700 · Cardiovascular
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).
2510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111007 | Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center…NMD · Traditional | Midwest Reprocessing Center, LLC | 06/08/2011SE |
| K100523 | Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model…NMD · Traditional | Hygia Health Services, Inc. | 05/04/2010SE |