DeviceClearance

Product code DSM— Cardiovascular

ELECTROCARDIOGRAPHIC ECG RECORDER

Classification name
Alarm, Leakage Current, Portable
Device class
Class 1
Regulation
21 CFR 870.2640
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

Market context for product code DSM

FDA has cleared 1 device under product code DSM, all in 1978, filed by 1 applicant company. 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.

Top applicants under product code DSM

Recent clearances under product code DSM

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