Cleared Traditional

CPR Face Shield

K192285 · Firstar Healthcare Company Limited (Guangzhou) · Anesthesiology
Nov 2020
Decision
461d
Days
Class 2
Risk

About This 510(k) Submission

K192285 is an FDA 510(k) clearance for the CPR Face Shield, a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Firstar Healthcare Company Limited (Guangzhou) (Guangzhou, CN). The FDA issued a Cleared decision on November 25, 2020, 461 days after receiving the submission on August 22, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K192285 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2019
Decision Date November 25, 2020
Days to Decision 461 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CBP — Valve, Non-rebreathing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5870

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