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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 K243468
Device Name Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
Applicant
Joytech Healthcare Co. , Ltd.
# 365. Wuzhou Rd., Yuhang Economic Development Zone
Hangzhou,  CN 311100
Applicant Contact Jing Cong
Correspondent
Chonconn Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Jie Yang
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/08/2024
Decision Date 07/02/2025
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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