510(k) K820482

ACCU-RYNGE INSULIN PUMP #SP-250 by Delta Medical Industries — Product Code FRN

K820482 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "ACCU-RYNGE INSULIN PUMP #SP-250". The FDA issued a decision of Substantially Equivalent on March 26, 1982. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Delta Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1982
Date Received
February 22, 1982
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