Product code DRJ— Cardiovascular

AMPLIFIER MODEL N5A-ECG

Classification name: System, Signal Isolation
Device class: Class 1
Regulation: 21 CFR 870.2600
Advisory panel: Cardiovascular
Total cleared: 4
First cleared: 1977-09-14
Most recent: 1984-05-09

Market context for product code DRJ

FDA has cleared 4 devices under product code DRJ between 1977 and 1984, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19841 clearance
19821 clearance
19772 clearances

Top applicants under product code DRJ

Honeywell, Inc.3 clearances
Clinical Data Instruments, Inc.1 clearance

Recent clearances under product code DRJ

K832828 — CENTURION CARDIAC DETECTORClinical Data Instruments, Inc.·1984-05-09
K822590 — PRESSURE ISOLATION AMPLIFIER #9813 517Honeywell, Inc.·1982-10-04
K771684 — AMPLIFIER MODEL N5A-ECGHoneywell, Inc.·1977-09-14
K771685 — AMPLIFIER MODEL N5A-HISHoneywell, Inc.·1977-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.