FDA 510(k) Applications Submitted by Johnny Johnny
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K111141 |
04/22/2011 |
BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR |
WENZHOU BOKANG INSTRUMENTS CO., LTD. |
| K203078 |
10/13/2020 |
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW |
HuiZhou TianChang Industrial Co., Ltd |
| K220309 |
02/02/2022 |
Wearable Breast Pump (Model S10) |
Shenzhen Lutejiacheng Technology Co., Ltd. |
| K153545 |
12/11/2015 |
Portable Slit Lamp |
SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. |
| K192290 |
08/23/2019 |
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown |
Xuchang Zhengde Environstar Medical Products Co., Ltd |
| K003521 |
11/14/2000 |
DISPO-MED 7.6 LITER SHARPS CONTAINER |
MASTER BENEFITS, INC. |
| K101305 |
05/10/2010 |
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL |
ARK DIAGNOSTICS,INC |
| K101574 |
06/07/2010 |
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 |
ARK DIAGNOSTICS,INC |
| K091653 |
06/09/2009 |
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 |
ARK DIAGNOSTICS,INC |
| K091884 |
06/24/2009 |
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 |
ARK DIAGNOSTICS,INC |
| K083799 |
12/22/2008 |
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 |
ARK DIAGNOSTICS,INC |
| K143129 |
10/31/2014 |
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) |
EziSurg Medical Co.,Ltd. |
| K020449 |
02/11/2002 |
CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM |
CARDIONOW, INC. |
| K002597 |
08/21/2000 |
CN ACQUISITION STATION |
CARDIONOW, INC. |
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