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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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powered wheelchair The Oec Group k811656 06/25/1981
powered wheelchair (nxn20-208, nxn20-211) Zhejiang Nysin Medical Co., Ltd. k241603 11/20/2024
powerpicc sv catheters C.R. Bard, Inc. k102159 11/17/2010
premise series bed Batesville American Mfg. Co. k890845 06/15/1989
press-o-test Medi-Swiss Corp. k822102 11/24/1982
primidone (fpia) calibrator kit Tudor Laboratories, Inc. k895568 09/28/1989
pristine/blooming/pristine blooming culture cath Hall/Mccollum Laboratories, Inc. k862098 11/12/1986
privatan home tanning center Privatan, Inc. k852290 06/21/1985
protologic model ser-1 Protologic, Inc. k894936 01/22/1990
pulse oximeter Beijing Choice Electronic Technology Co., Ltd. k220101 03/08/2023

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