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

Monitor, St Segment

21 CFR 870.2340 / Cardiovascular
FDA source (opens on fda.gov)

MLC is the FDA product code for Monitor, St Segment, a class II device type, regulated under 21 CFR 870.2340. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MLC
Device name
Monitor, St Segment
Regulation
21 CFR 870.2340
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 MLC

By decision year
2 clearances under product code MLC with a decision year between 1993 and 2000, 1993 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MLC by decision year
YearClearances
19931
20001

Applicants with the most clearances

Product code MLC
Applicants holding the most 510(k) clearances under product code MLC
ApplicantClearances
Datascope Corp.1
Draeger, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code