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

Monitor, Blood-Flow, Cerebral, Thermal Diffusion

Unknown
FDA source (opens on fda.gov)

LME is the FDA product code for Monitor, Blood-Flow, Cerebral, Thermal Diffusion, a class III device type. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LME
Device name
Monitor, Blood-Flow, Cerebral, Thermal Diffusion
Device class
Class III
Review panel
Unknown
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code LME

By decision year
1 clearance under product code LME with a decision year between 1985 and 1985, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LME by decision year
YearClearances
19851

Applicants with the most clearances

Product code LME
Applicants holding the most 510(k) clearances under product code LME
ApplicantClearances
Flowtronics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LME.