NMD · Class II · 21 CFR 870.2700

FDA Product Code NMD: Oximeter, Tissue Saturation, Reprocessed

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).

Leading manufacturers include Hygia Health Services, Inc. and Midwest Reprocessing Center, LLC.

2
Total
2
Cleared
64d
Avg days
2010
Since

FDA 510(k) Cleared Oximeter, Tissue Saturation, Reprocessed Devices (Product Code NMD)

2 devices
1–2 of 2
Cleared Jun 08, 2011
MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS
K111007
Midwest Reprocessing Center, LLC
Cardiovascular · 58d
Cleared May 04, 2010
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
K100523
Hygia Health Services, Inc.
Cardiovascular · 69d

About Product Code NMD - Regulatory Context