The following data is part of a premarket notification filed by Hypnocore, Ltd. with the FDA for Hc1000p Sleep Diagnosis Software System.
| Device ID | K073269 |
| 510k Number | K073269 |
| Device Name: | HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM |
| Classification | Ventilatory Effort Recorder |
| Applicant | HYPNOCORE, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub HYPNOCORE, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-21 |
| Decision Date | 2008-04-18 |
| Summary: | summary |