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510(k) K192285

CPR Face Shield by Firstar Healthcare Company Limited (Guangzhou) — Product Code CBP

K192285 is an FDA 510(k) premarket notification submitted by Firstar Healthcare Company Limited (Guangzhou) for the device "CPR Face Shield". The FDA issued a decision of Substantially Equivalent on November 25, 2020. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2020
Date Received
August 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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  • K234053 — F&P Optiflow Flow Diverter (August 9, 2024)
  • K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb) (December 23, 2021)
  • K173770 — OJR215 Pressure Relief Manifold (April 5, 2019)
  • K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo (November 17, 2017)
  • K152521 — Seal Rite Non-Rebreathing Valve (June 3, 2016)
  • K142764 — KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (July 9, 2015)
  • K142402 — BigEasy Non-Rebreathing Valve (March 23, 2015)
  • K132143 — EXHALATION VALVE (June 4, 2014)
  • K112126 — GENUINE FIRST AID CPR MASK (December 1, 2011)

FDA data resources