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Oximeter, Tissue Saturation, Reprocessed

FDA product code NMD · 2 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2700
Review panel
CV
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2010-05-04 – 2011-06-08

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).

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