The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Apnoescreen Pro, Alpha Screen Pro.
| Device ID | K000396 |
| 510k Number | K000396 |
| Device Name: | APNOESCREEN PRO, ALPHA SCREEN PRO |
| Classification | Ventilatory Effort Recorder |
| Applicant | ERICH JAEGER, INC. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Larry Murdock |
| Correspondent | Larry Murdock ERICH JAEGER, INC. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-12-27 |