The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Live View Panel (lvp).
| Device ID | K131415 |
| 510k Number | K131415 |
| Device Name: | LIVE VIEW PANEL (LVP) |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | NEUROTRONICS, INC. 3600 NW 43RD ST, STE F1 Gainesville, FL 32606 |
| Contact | David Pezet |
| Correspondent | David Pezet NEUROTRONICS, INC. 3600 NW 43RD ST, STE F1 Gainesville, FL 32606 |
| Product Code | OLV |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-16 |
| Decision Date | 2013-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817111020816 | K131415 | 000 |
| 00817111020786 | K131415 | 000 |