Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

DSK

Computer, Blood-Pressure

Product code
DSK
Device name
Computer, Blood-Pressure
Device class
Class 2
21 CFR
21 CFR 870.1110
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
77 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-11-03.

NumberDecision dateApplicantDevice nameSummary
K2315862023-11-03Endophys Technologies, LLCEndophys Blood Pressure Monitor model BPM-30FDA
Official FDA classification page: DSK
Classification and pathway per current FDA publications. Data from openFDA (CC0).