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

Monitor, Line Isolation

21 CFR 870.2620 / Cardiovascular
FDA source (opens on fda.gov)

DRI is the FDA product code for Monitor, Line Isolation, a class I device type, regulated under 21 CFR 870.2620. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DRI
Device name
Monitor, Line Isolation
Regulation
21 CFR 870.2620
Device class
Class I
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code DRI

By decision year
4 clearances under product code DRI with a decision year between 1980 and 1990, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DRI by decision year
YearClearances
19801
19821
19902

Applicants with the most clearances

Product code DRI
Applicants holding the most 510(k) clearances under product code DRI
ApplicantClearances
Datex Division Instrumentarium Corp.2
Hmba1
Stanco Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code