Atlas FDA

CPR Face Shield

FDA 510(k) clearance K192285 · decided 2020-11-25

Clearance details

K-number
K192285
Device name
CPR Face Shield
Applicant
Firstar Healthcare Company Limited (Guangzhou)
Decision
Substantially Equivalent
Date received
2019-08-22
Decision date
2020-11-25
Days to decision
461 days
Clearance type
Traditional
Product code
CBP
Device class
2
Regulation number
868.5870
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Guangzhou, CN
Third-party review
No
Expedited review
No

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OJR215 Pressure Relief Manifold (K173770)Fisher & Paykel Healthcare Limited2019-04-05
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) (K171961)Xiamen Compower Medical Tech. Co., Ltd.2017-11-17
Seal Rite Non-Rebreathing Valve (K152521)The Lifeguard Store, Inc.2016-06-03
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (K142764)Hangzhou Jinlin Medical Appliances Co., Ltd.2015-07-09
BigEasy Non-Rebreathing Valve (K142402)12th Man Technologies, Inc.2015-03-23
EXHALATION VALVE (K132143)Intersurgical Incorporated2014-06-04
GENUINE FIRST AID CPR MASK (K112126)Genuine First Aid, LLC2011-12-01
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE (K111191)Wet Nose Technologies, LLC2011-07-28
CPR FACE MASK (K102299)Genuine First Aid, LLC2011-03-18

Recalls involving this device

No recalls on record reference this clearance.