510(k) K873875

BAXA EXACTA-MED PHARMACY PUMP by Baxa Corp., Sub. of Cook Group, Inc. — Product Code FRN

K873875 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "BAXA EXACTA-MED PHARMACY PUMP". The FDA issued a decision of Substantially Equivalent on November 24, 1987. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1987
Date Received
September 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type