NMD — Oximeter, Tissue Saturation, Reprocessed Class II
FDA product code NMD covers "Oximeter, Tissue Saturation, Reprocessed", a Class II medical device regulated under 21 CFR 870.2700. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NMD
- Device Class
- Class II
- Regulation Number
- 870.2700
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K111007 | midwest reprocessing center | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTE | June 8, 2011 |
| K100523 | hygia health services | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENS | May 4, 2010 |