510(k) K770730

PUMP, INFUSION, DYNATECH/HANDLEY by Dynatech Medical Products — Product Code FRN

K770730 is an FDA 510(k) premarket notification submitted by Dynatech Medical Products for the device "PUMP, INFUSION, DYNATECH/HANDLEY". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Dynatech Medical Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
April 20, 1977
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