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U.S. Department of Health and Human Services

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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pulmanex tm (modification) Life Design Systems, Inc. k863026 08/26/1986
purges lines, pl-45 & pl-33 American Bentley k833048 10/20/1983
q-lux plasma 100 light cure unit Rolence Enterprise Co. , Ltd. k001719 10/10/2000
qms lidocaine Thermo Fisher Scientific, Inc. k090282 05/29/2009
quantum perfusion dual lumen cannula 31f, quantum perfusion dual lumen cannula 27f, quantum perfusion dual lumen cannula 24f, quantum perfusion dual lumen cannula 29f, quantum perfusion dual lumen cannula 24f-v1, quantum perfusion dual lumen cannula 27f-v1, quantum perfusion dual lumen cannula 29f-v1, quantum perfusion dual lumen cannula 27f-vs, quantum perfusion dual lumen cannula 31f-vs Qura S.R.L k221353 08/18/2022
radio frequency system Shenzhenshi Sincoheren S&T Development Co., Ltd. k231749 10/19/2023
radionics rf disc catheter electrode system Radionics, Inc. k001741 10/23/2000
radview imager system General Electric Co. k790942 06/27/1979
razor, schick disposable Parke-Davis Co. k760342 08/11/1976
reagents for determ. co2 in human serum Diagnostic Solutions, Inc. k800681 05/30/1980

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