FDA 510(k) Applications Submitted by Michele Chin-Purcell

FDA 510(k) Number Submission Date Device Name Applicant
K191435 05/30/2019 IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 Nalu Medical, Inc.
K201618 06/15/2020 Nalu Neurostimulation SCS system Nalu Medical, Inc
K111917 07/06/2011 NUVANT, MOBILE CARDIAC TELEMETRY CORVENTIS, INC.
K202274 08/11/2020 Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscell Nalu Medical, Inc.
K183047 11/02/2018 Nalu Neurostimulation System Nalu Medical, Inc
K183579 12/21/2018 Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneou Nalu Medical, Inc


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