510(k) K110989 ยท ETN Stimulator, Nerve
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
| Applicant | Neurovision Medical Products, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Nov 3, 2011 |
| Received | Apr 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110989
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2024 | Neurovision Medical Products Inc Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO Open, Classified |
ETN | None listed |
| Jul 21, 2020 | Neurovision 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/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment Terminated |
ETN | None listed |
| Jul 21, 2020 | Neurovision Medical Products Inc Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessme Terminated |
ETN | None listed |
| Jul 21, 2020 | Neurovision 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/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment Terminated |
ETN | None listed |
| Jul 21, 2020 | Neurovision Medical Products Inc Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the la Terminated |
ETN | None listed |
| Jul 21, 2020 | Neurovision Medical Products Inc Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the l Terminated |
ETN | None listed |
| Jul 21, 2020 | Neurovision Medical Products Inc Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the la Terminated |
ETN | None listed |
| Jul 21, 2020 | Neurovision 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 |
ETN | None listed |
| Jul 21, 2020 | Neurovision 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 |
ETN | None listed |
| Jul 21, 2020 | Neurovision 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 |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.