FDA Product Code DXH: Transmitters And Receivers, Electrocardiograph, Telephone

510(k) Submission Activity

297 total 510(k) submissions under product code DXH since 1976, with 297 receiving FDA clearance (average review time: 145 days).

Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.

FDA Review Time

Recent submissions under DXH have taken an average of 337 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.