Atlas FDA

COMPLETE CPR KIT

FDA 510(k) clearance K941008 · decided 1994-11-10

Clearance details

K-number
K941008
Device name
COMPLETE CPR KIT
Applicant
Mtm Health Products , Ltd.
Decision
Unknown
Date received
1994-03-01
Decision date
1994-11-10
Days to decision
254 days
Clearance type
Traditional
Product code
CBP
Device class
2
Regulation number
868.5870
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
L7r 2e3, CA
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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CPR Face Shield (K192285)Firstar Healthcare Company Limited (Guangzhou)2020-11-25
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

Recalls involving this device

No recalls on record reference this clearance.