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

Tester, Electrode, Surface, Electrocardiographic

21 CFR 870.2370 / Cardiovascular
FDA source (opens on fda.gov)

KRC is the FDA product code for Tester, Electrode, Surface, Electrocardiographic, a class II device type, regulated under 21 CFR 870.2370. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KRC
Device name
Tester, Electrode, Surface, Electrocardiographic
Regulation
21 CFR 870.2370
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
11
Ingested recalls
0

Clearances, product code KRC

By decision year
11 clearances under product code KRC with a decision year between 1977 and 2004, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KRC by decision year
YearClearances
19771
19781
19811
19832
19842
19873
20041

Applicants with the most clearances

Product code KRC
Applicants holding the most 510(k) clearances under product code KRC
ApplicantClearances
Circadian, Inc.2
Aequitron Medical, Inc.1
Delta Medical Industries1
E.B.S., Inc.1
General Devices1
Gerard Medical Enterprises, Inc.1
Lintronics Industries, Inc.1
Marquette Electronics, Inc.1
Mg Medical Electronics1
Sontra Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code