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

HGZ

Heater, Perineal, Direct Contact

Product code
HGZ
Device name
Heater, Perineal, Direct Contact
Device class
Class 2
21 CFR
21 CFR 884.5390
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K) Exempt
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)
Official FDA classification page: HGZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).