The JLN-23XX Series Piston Compress Nebulizer (with Models JLN-2300AS, JLN-2301AS, JLN-2317AS And JLN-2320AS)

Nebulizer (direct Patient Interface)

SHENZHEN HOMED MEDICAL DEVICE CO., LTD

The following data is part of a premarket notification filed by Shenzhen Homed Medical Device Co., Ltd with the FDA for The Jln-23xx Series Piston Compress Nebulizer (with Models Jln-2300as, Jln-2301as, Jln-2317as And Jln-2320as).

Pre-market Notification Details

• Device ID: K161586
• 510k Number: K161586
• Device Name: The JLN-23XX Series Piston Compress Nebulizer (with Models JLN-2300AS, JLN-2301AS, JLN-2317AS And JLN-2320AS)
• Classification: Nebulizer (direct Patient Interface)
• Applicant: SHENZHEN HOMED MEDICAL DEVICE CO., LTD NO.2 BUILDING, LONGGU INDUSTRIAL ZONE, LONGHUA TOWN Shenzhen, CN 518109
• Contact: Shengming Shi
• Correspondent: Shengming Shi; SHENZHEN HOMED MEDICAL DEVICE CO., LTD NO.2 BUILDING, LONGGU INDUSTRIAL ZONE, LONGHUA TOWN Shenzhen, CN 518109
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-08
• Decision Date: 2017-09-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10822383986620	K161586	000
00822383548760	K161586	000
00822383548753	K161586	000
00822383537078	K161586	000
00822383519180	K161586	000
00822383509150	K161586	000
00822383506036	K161586	000
00822383295121	K161586	000
M368JB01120902	K161586	000
M368JB01121112	K161586	000
M368JB01121101	K161586	000
50822383023132	K161586	000
00822383551029	K161586	000
00822383554914	K161586	000
00822383569123	K161586	000
10822383986613	K161586	000
50890124000018	K161586	000
00822383963709	K161586	000
00822383563060	K161586	000
00822383295022	K161586	000
00885304006794	K161586	000
00885304001508	K161586	000
00885304000822	K161586	000
00822383986623	K161586	000
00822383986616	K161586	000
00822383569130	K161586	000
00822383023120	K161586	000