FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
K Number: K130806
·
Decision Jul 12, 2013
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
33
Applicant Total
9
Review Days
109
Basic Information
- Device Name
- NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
- K Number
- K130806
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NEUROVISION MEDICAL PRODUCTS, INC.
- Date Received
- March 25, 2013
- Decision Date
- July 12, 2013
- Product Code
- PDQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by NEUROVISION MEDICAL PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | Dec 26, 2013 | Substantially Equivalent |
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | Dec 13, 2012 | Substantially Equivalent |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | Oct 19, 2012 | Substantially Equivalent |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Nov 3, 2011 | Substantially Equivalent |
| K110140 | NEUROVISION NERVE LOCATOR MONITOR | Sep 30, 2011 | Substantially Equivalent |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | Jun 28, 2011 | Substantially Equivalent |
| K110138 | PAIRED HYDROGEL ELECTRODE | Apr 8, 2011 | Substantially Equivalent |
| K102862 | NEUROVISION SE (NERVEANA) | Dec 21, 2010 | Substantially Equivalent |