510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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|---|---|---|---|
| ximatron v | Siemens Corp. | k810858 |
05/13/1981 |
| multipro catheter | Shiley, Inc. | k841797 |
08/10/1984 |
| modified silicone dual lumen subclavian cannula | Shiley, Inc. | k863697 |
10/02/1986 |
| lancer analyzer cups | Sherwood Medical Co. | k833157 |
12/08/1983 |
| zentite (unicorn+); zentite (unicorn+i); zentite (unicorn+ii); zentite (unicorn+iii) | Shenzhen Peninsula Medical Group | k254290 |
01/30/2026 |
| accutorr 7/vs-900/vs-900c vital signs monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | k182821 |
03/27/2019 |
| narrowband uv phototherapy light lamp (model: hb-upll-01, hb-upll-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | k223882 |
03/27/2023 |
| air compression therapy device | Shenzhen Dongjilian Electronics Co., Ltd. | k201694 |
11/19/2020 |
| share int'l tdm | Share Int'L | k832067 |
10/27/1983 |
| adhesive electrode | Shaoxing Yingtuo Healthcare Co., Ltd. | k210448 |
08/31/2021 |
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