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

System, Signal Isolation

21 CFR 870.2600 / Cardiovascular
FDA source (opens on fda.gov)

DRJ is the FDA product code for System, Signal Isolation, a class I device type, regulated under 21 CFR 870.2600. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DRJ
Device name
System, Signal Isolation
Regulation
21 CFR 870.2600
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
0

Clearances, product code DRJ

By decision year
4 clearances under product code DRJ with a decision year between 1977 and 1984, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DRJ by decision year
YearClearances
19772
19821
19841

Applicants with the most clearances

Product code DRJ
Applicants holding the most 510(k) clearances under product code DRJ
ApplicantClearances
Honeywell, Inc.3
Clinical Data Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code