The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Silenzio Plus Continuous Positive Airway Pressure System.
| Device ID | K962492 |
| 510k Number | K962492 |
| Device Name: | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL 35217 |
| Contact | Gregg Gaskins |
| Correspondent | Gregg Gaskins NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL 35217 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-26 |
| Decision Date | 1997-01-23 |