ClearanceBrief
510(k) K110989 ยท ETN Stimulator, Nerve

NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

ApplicantNeurovision Medical Products, Inc., Ventura CA, US
DecisionSubstantially Equivalent, Nov 3, 2011
ReceivedApr 8, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K110989

DateFirm and productCodeLinked 510(k)
Aug 23, 2024Neurovision Medical Products Inc
Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO
Open, Classified
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment
Terminated
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessme
Terminated
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment
Terminated
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the la
Terminated
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the l
Terminated
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the la
Terminated
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying t
Terminated
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngea
Terminated
ETNNone listed
Jul 21, 2020Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngea
Terminated
ETNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.