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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K230379
Device Name Portable (Ultrasonic) Nebulizer
Applicant
Dongguan Simzo Electronic Technology Co., Ltd.
# 6 Zhangzhou Rd., Daojiao Town
Dongguan City,  CN 523187
Applicant Contact Jack Jin
Correspondent
Shenzhen Reanny Medical Devices Management Consulting., Ltd.
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/13/2023
Decision Date 11/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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