Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube
FDA 510(k) K094054 · Nuvasive, Inc.
510(k) numberK094054
Submission
- Device name
- Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- December 31, 2009
- Decision date
- May 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube cleared by the FDA?
Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube (K094054) received a 510(k) decision of Substantially Equivalent on May 14, 2010, 134 days after the submission was received.
What is the product code of K094054?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.