510(k) K220695

Elite Biomedical Solutions Dose Request Cord by Elite Biomedical Solutions — Product Code MRZ

K220695 is an FDA 510(k) premarket notification submitted by Elite Biomedical Solutions for the device "Elite Biomedical Solutions Dose Request Cord". The FDA issued a decision of Substantially Equivalent on April 29, 2022. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2022
Date Received
March 9, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type