The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Neurotronics Polysomnography System 101.
| Device ID | K971803 |
| 510k Number | K971803 |
| Device Name: | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 |
| Classification | Ventilatory Effort Recorder |
| Applicant | NEUROTRONICS, INC. 20825 NE 132ND AVE. Waldo, FL 32694 |
| Contact | Jack R Smith |
| Correspondent | Jack R Smith NEUROTRONICS, INC. 20825 NE 132ND AVE. Waldo, FL 32694 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1997-11-12 |
| Summary: | summary |