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510(k) K111007

MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE by Midwest Reprocessing Center, LLC — Product Code NMD

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).

Other clearances by Midwest Reprocessing Center, LLC

  • K101280 — MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (October 7, 2010)
  • K101330 — MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST (August 27, 2010)
  • K101702 — MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS (August 27, 2010)

Other clearances for product code NMD

  • K100523 — ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENS (May 4, 2010)