The following data is part of a premarket notification filed by Resmed Germany Inc. with the FDA for Apnealink Pro.
| Device ID | K131932 |
| 510k Number | K131932 |
| Device Name: | APNEALINK PRO |
| Classification | Ventilatory Effort Recorder |
| Applicant | RESMED GERMANY INC. FRAUNHOFERSTRASSE 16 Martinsried, DE D-82152 |
| Contact | Sandra Grunwald |
| Correspondent | Sandra Grunwald RESMED GERMANY INC. FRAUNHOFERSTRASSE 16 Martinsried, DE D-82152 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-06-27 |
| Decision Date | 2013-11-08 |
| Summary: | summary |