The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Cp-90 Continuous Positive Airway Pressure System.
| Device ID | K952966 |
| 510k Number | K952966 |
| Device Name: | CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-27 |
| Decision Date | 1996-05-07 |