510(k) K932544

IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 by Y — Product Code FRN

K932544 is an FDA 510(k) premarket notification submitted by Y for the device "IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599". The FDA issued a decision of Substantially Equivalent on October 12, 1993. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Y has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1993
Date Received
May 26, 1993
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