The following data is part of a premarket notification filed by Del Mar Reynolds Medical, Inc. with the FDA for Lifescreen Apnea.
| Device ID | K042745 |
| 510k Number | K042745 |
| Device Name: | LIFESCREEN APNEA |
| Classification | Ventilatory Effort Recorder |
| Applicant | DEL MAR REYNOLDS MEDICAL, INC. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers DEL MAR REYNOLDS MEDICAL, INC. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2005-01-19 |
| Summary: | summary |