510(k) K111007
K111007 is an FDA 510(k) premarket notification submitted by Midwest Reprocessing Center, LLC for the device "MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE". The FDA issued a decision of Substantially Equivalent on June 8, 2011. The device falls under product code NMD (Oximeter, Tissue Saturation, Reprocessed), a Class II device regulated under 21 CFR 870.2700. Midwest Reprocessing Center, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2011
- Date Received
- April 11, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter, Tissue Saturation, Reprocessed
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- CV
- Submission Type
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).