Cleared Traditional

Natural Rubber Latex Ultrasound Transducer Probe Covers

K213087 · Global Protection Corp. · Radiology
Jun 2022
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K213087 is an FDA 510(k) clearance for the Natural Rubber Latex Ultrasound Transducer Probe Covers, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Global Protection Corp. (Boston, US). The FDA issued a Cleared decision on June 7, 2022, 256 days after receiving the submission on September 24, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K213087 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2021
Decision Date June 07, 2022
Days to Decision 256 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code ITX — Transducer, Ultrasonic, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

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