The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Serenity Body Position Sensor, Serenity Rip Sensors.
| Device ID | K173868 |
| 510k Number | K173868 |
| Device Name: | Serenity Body Position Sensor, Serenity RIP Sensors |
| 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 |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817111021134 | K173868 | 000 |
| 00817111020830 | K173868 | 000 |
| 00817111020847 | K173868 | 000 |
| 00817111020854 | K173868 | 000 |
| 00817111020861 | K173868 | 000 |
| 00817111020878 | K173868 | 000 |
| 00817111020885 | K173868 | 000 |
| 00817111020892 | K173868 | 000 |
| 00817111020908 | K173868 | 000 |
| 00817111020915 | K173868 | 000 |
| 00817111020922 | K173868 | 000 |
| 00817111020939 | K173868 | 000 |
| 00817111020946 | K173868 | 000 |
| 00817111020953 | K173868 | 000 |
| 00817111021103 | K173868 | 000 |
| 00817111021110 | K173868 | 000 |
| 00817111021127 | K173868 | 000 |
| 00817111020823 | K173868 | 000 |