The following data is part of a premarket notification filed by Resmed Germany Inc. with the FDA for Apnealink Plus, Model: 22328.
| Device ID | K083575 |
| 510k Number | K083575 |
| Device Name: | APNEALINK PLUS, MODEL: 22328 |
| Classification | Ventilatory Effort Recorder |
| Applicant | RESMED GERMANY INC. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
| Contact | David D'cruz |
| Correspondent | David D'cruz RESMED GERMANY INC. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2009-03-19 |
| Summary: | summary |