Recorder, Magnetic Tape, Medical

What Is FDA Product Code DSH?

Recorder, Magnetic Tape, Medical is FDA product code DSH, Class 2, 21 CFR 870.2800.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 3 clearances under this code; the FDA took a median of 245 days from receipt to decision on them.

1 was reviewed by an accredited third party.