Cleared Traditional

Elite Biomedical Solutions Dose Request Cord

K220695 · Elite Biomedical Solutions · General Hospital
Apr 2022
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K220695 is an FDA 510(k) clearance for the Elite Biomedical Solutions Dose Request Cord, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Elite Biomedical Solutions (Cincinnati, US). The FDA issued a Cleared decision on April 29, 2022, 51 days after receiving the submission on March 9, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K220695 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2022
Decision Date April 29, 2022
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MRZ — Accessories, Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725