The following data is part of a premarket notification filed by Medical Measurement Systems,b.v. with the FDA for Solar Gi.
| Device ID | K052338 |
| 510k Number | K052338 |
| Device Name: | SOLAR GI |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MEDICAL MEASUREMENT SYSTEMS,B.V. COLOSSEUM 25 Enschede, NL 7521 Pv |
| Contact | Karin Ogink-somhorst |
| Correspondent | Karin Ogink-somhorst MEDICAL MEASUREMENT SYSTEMS,B.V. COLOSSEUM 25 Enschede, NL 7521 Pv |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-26 |
| Decision Date | 2005-12-15 |