510(k) K820963

PATIENT PAL I.V. WALKER by Pryor Products — Product Code FOX

K820963 is an FDA 510(k) premarket notification submitted by Pryor Products for the device "PATIENT PAL I.V. WALKER". The FDA issued a decision of Substantially Equivalent on April 21, 1982. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Pryor Products has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1982
Date Received
April 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Infusion
Device Class
Class I
Regulation Number
880.6990
Review Panel
HO
Submission Type