510(k) K823226

SN-100 DOCTOR'S ROUND by Kells Medical, Inc. — Product Code ETF

K823226 is an FDA 510(k) premarket notification submitted by Kells Medical, Inc. for the device "SN-100 DOCTOR'S ROUND". The FDA issued a decision of Substantially Equivalent on November 22, 1982. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. Kells Medical, Inc. has at least 10 other 510(k) clearances on record.