510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NMDClass II

Oximeter, Tissue Saturation, Reprocessed

21 CFR 870.2700 / Cardiovascular
FDA source (opens on fda.gov)

NMD is the FDA product code for Oximeter, Tissue Saturation, Reprocessed, a class II device type, regulated under 21 CFR 870.2700. FDA's definition for this code reads: "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)". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NMD
Device name
Oximeter, Tissue Saturation, Reprocessed
FDA 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).
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code NMD

By decision year
2 clearances under product code NMD with a decision year between 2010 and 2011, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NMD by decision year
YearClearances
20101
20111

Applicants with the most clearances

Product code NMD
Applicants holding the most 510(k) clearances under product code NMD
ApplicantClearances
Hygia Health Services, Inc.1
Midwest Reprocessing Center, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code