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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 6 of 6 Results
ProductCode: ODG Applicant: PENTAX OF AMERICA, INC. Decision Date To: 05/04/2024
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pentax medical ultrasound upper gi video scope eg34-j10u, pentax medical ultrasound upper gi video scope eg36-j10ur, pentax medical ultrasound upper gi video scope eg38-j10ut, pentax medical ultrasound video bronchoscope eb19-j10u PENTAX of America, Inc. K203166 12/30/2020
pentax medical eg-j10u endoscopic ultrasound system - eg34-j10u ultrasound upper gi video scope (convex array type), eg36-j10ur ultrasound upper gi video scope (radial array type), eg38-j10ut ultrasound upper gi video scope (convex array type) PENTAX of America, Inc. K200090 07/23/2020
pentax medical endoscopic ultrasound system PENTAX of America, Inc. K182004 08/21/2018
pentax medical endoscopic ultrasound system, eg-3270uk upper g.i. video scope (convex array type) with epk-i5010 video processor and hi vision preirus ultrasound scanner PENTAX of America, Inc. K162447 04/13/2017
pentax eg-3670urk ultrasound video gastroscope + hi vision preirus PENTAX OF AMERICA, INC. K130206 03/20/2013
pentax eg-3870utk ultrasound video gastroscope + hi vision preirus PENTAX OF AMERICA, INC. K130247 03/20/2013
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