Oximeter, Tissue Saturation, Reprocessed
The Reprocessed Tissue Saturation Oximeter is a reprocessed cardiovascular monitoring device used to measure regional tissue oxygen saturation (rSO2), typically using near-infrared spectroscopy applied transcutaneously; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NMD and regulation 21 CFR 870.2700 in the Cardiovascular specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NMD
- Device Class
- FDA class 2
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111007 | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE | Jun 08, 2011 | Substantially Equivalent | Midwest Reprocessing Center, LLC |
| K100523 | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA | May 04, 2010 | Substantially Equivalent | Hygia Health Services, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.