FDA Product Code DSH: Recorder, Magnetic Tape, Medical
Leading manufacturers include Edan Instruments, Inc., MEZOO Co., Ltd. and Wellysis Corp..
FDA 510(k) Cleared Recorder, Magnetic Tape, Medical Devices (Product Code DSH)
About Product Code DSH - Regulatory Context
510(k) Submission Activity
194 total 510(k) submissions under product code DSH since 1976, with 194 receiving FDA clearance (average review time: 125 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under DSH have taken an average of 231 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.
DSH devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →