NMD · Oximeter, Tissue Saturation, Reprocessed
Cardiovascular · 21 CFR 870.2700 · Class 2
Overview
| Product Code | NMD |
|---|---|
| Device Name | Oximeter, Tissue Saturation, Reprocessed |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K111007 | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE | Midwest Reprocessing Center, LLC | Jun 8, 2011 | SESE |
| K100523 | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA | Hygia Health Services, Inc. | May 4, 2010 | SESE |
Top Applicants
- Hygia Health Services, Inc. — 1 clearance
- Midwest Reprocessing Center, LLC — 1 clearance
