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 |