Cleared Traditional

RFP-100A Connector Cable (Single Use)

K230571 · Baylis Medical Technologies, Inc. · Cardiovascular
May 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K230571 is an FDA 510(k) clearance for the RFP-100A Connector Cable (Single Use), a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Baylis Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on May 30, 2023, 90 days after receiving the submission on March 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K230571 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2023
Decision Date May 30, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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