510(k) K881977

PRESSURE INFUSOR by Primrose Medical, Inc. — Product Code KZD

K881977 is an FDA 510(k) premarket notification submitted by Primrose Medical, Inc. for the device "PRESSURE INFUSOR". The FDA issued a decision of Substantially Equivalent on July 29, 1988. The device falls under product code KZD (Infusor, Pressure, For I.V. Bags), a Class I device regulated under 21 CFR 880.5420. Primrose Medical, Inc. has at least 10 other 510(k) clearances on record.