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).
| 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 |
| 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 |
| 00822383023120 | K161586 | 000 |
| 00822383551029 | K161586 | 000 |
| 00822383554914 | 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 |
| 00822383569123 | K161586 | 000 |
| 10810113578566 | K161586 | 000 |