The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Polysmith Sleep System, Model Nti5498.
| Device ID | K062943 |
| 510k Number | K062943 |
| Device Name: | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | NEUROTRONICS, INC. 102 N.E. 10TH AVE., SUITE 5 Gainesville, FL 32601 |
| Contact | Jennifer Laine |
| Correspondent | Jennifer Laine NEUROTRONICS, INC. 102 N.E. 10TH AVE., SUITE 5 Gainesville, FL 32601 |
| Product Code | OLZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2007-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817111020793 | K062943 | 000 |
| 00817111020779 | K062943 | 000 |
| 00817111020755 | K062943 | 000 |
| 00817111020748 | K062943 | 000 |
| 00817111021172 | K062943 | 000 |
| 00817111021257 | K062943 | 000 |