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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K244035

Portable mesh nebulizer (JM821) · Shenzhen Jermei Medical Device Technology Co., Ltd. · decided 2025-09-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
JermeiJM832Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811130
JermeiJM818Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811062
JermeiJM839Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811192
JermeiJM821Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811079
JermeiJM817Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811055
JermeiJM830Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811123
JermeiJM822Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811086
JermeiJM838Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811185
JermeiJM828Shenzhen Jermei Medical Device Technology Co.,LtdCAF06972433811109