The following data is part of a premarket notification filed by Erich Jaeger Gmbh with the FDA for Sleepscreen/apnoescreen Cardio.
| Device ID | K021138 |
| 510k Number | K021138 |
| Device Name: | SLEEPSCREEN/APNOESCREEN CARDIO |
| Classification | Ventilatory Effort Recorder |
| Applicant | ERICH JAEGER GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Brian Long |
| Correspondent | Brian Long ERICH JAEGER GMBH 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 | 2002-04-09 |
| Decision Date | 2003-02-12 |
| Summary: | summary |