The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Serenity Piezo Sensor, Serenity Thermocouple Sensor.
| Device ID | K181709 |
| 510k Number | K181709 |
| Device Name: | Serenity Piezo Sensor, Serenity Thermocouple Sensor |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | Neurotronics, Inc. 4500 NW 27th Ave Ste C2 Gainesville, FL 32606 |
| Contact | David Pezet |
| Correspondent | David Pezet Neurotronics, Inc. 4500 NW 27th Ave Ste C2 Gainesville, FL 32606 |
| Product Code | OLV |
| Subsequent Product Code | DQA |
| Subsequent Product Code | GWL |
| Subsequent Product Code | MNR |
| Subsequent Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-28 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817111021097 | K181709 | 000 |
| 00817111021165 | K181709 | 000 |
| 00817111020960 | K181709 | 000 |
| 00817111020977 | K181709 | 000 |
| 00817111020984 | K181709 | 000 |
| 00817111020991 | K181709 | 000 |
| 00817111021004 | K181709 | 000 |
| 00817111021011 | K181709 | 000 |
| 00817111021028 | K181709 | 000 |
| 00817111021035 | K181709 | 000 |
| 00817111021042 | K181709 | 000 |
| 00817111021059 | K181709 | 000 |
| 00817111021066 | K181709 | 000 |
| 00817111021073 | K181709 | 000 |
| 00817111021080 | K181709 | 000 |
| 00817111021158 | K181709 | 000 |