The following data is part of a premarket notification filed by Personal Health Institute International with the FDA for Galaxy System; Jupiter.
| Device ID | K111055 |
| 510k Number | K111055 |
| Device Name: | GALAXY SYSTEM; JUPITER |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | PERSONAL HEALTH INSTITUTE INTERNATIONAL 263 CEDAR CREEK DRIVE Battle Creek, MI 49015 |
| Contact | Kumar Kulkarni |
| Correspondent | Kumar Kulkarni PERSONAL HEALTH INSTITUTE INTERNATIONAL 263 CEDAR CREEK DRIVE Battle Creek, MI 49015 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-15 |
| Decision Date | 2011-12-21 |
| Summary: | summary |