510(k) K821377

AS 700 SERIES INFUSION PUMP ADMIN. by Narco Scientific — Product Code FPA

K821377 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "AS 700 SERIES INFUSION PUMP ADMIN.". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Narco Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
May 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type